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Glossary

Ambulatoria: An
outpatient clinic that together with the feldshersko-akusherski punkt
(FAP) is often the only source of healthcare available to patients in rural
areas.

Analgesic: A medicine
that reduces pain.

Central District Hospital: The
main health facility and administrative center for the public healthcare
system. Each of Ukraine’s 490 districts has one.

Chronic pain: Defined in
this report as pain that occurs over weeks, months, or years rather than a few
hours or days. Because of its duration, moderate to severe chronic pain should
be treated with oral opioids rather than repeated injections, especially for
people emaciated by diseases such as cancer and HIV/AIDS.

Controlled medicines: Medicines
that contain controlled substances.

Controlled substances:
Substances that are listed in one of the three international drug control
conventions: the Single Convention on Narcotic Drugs of 1961 as amended by the
1972 Protocol; the Convention on Psychotropic Substances of 1971; and the
United Nations Convention against Illicit Traffic in Narcotic Drugs and
Psychotropic Substances, 1988.

Dependence: Defined by the World Health
Organization (WHO) Expert Committee on Drug Dependence as a “cluster of
physiological, behavioral and cognitive phenomena of variable intensity, in which
the use of a psychoactive drug (or drugs) takes on a high priority. The
necessary descriptive characteristics are preoccupation with a desire to obtain
and take the drug and persistent drug-seeking behavior. Determinants and
problematic consequences of drug dependence may be biological, psychological or
social, and usually interact.”[1]
Dependence is clearly established to be a disorder. For Dependence syndrome,
WHO’s International classification of diseases, 10th Edition
(ICD-10), requires that three or more of the following six characteristic
features have been experienced or exhibited:

A strong desire or sense of compulsion to take the substance;

Difficulty controlling the onset, termination, and levels of use of
substance-taking behavior;

Physiological withdrawal state when substance use has ceased or been
reduced, as evidenced by: the characteristic withdrawal syndrome for the
substance; or use of the same (or a closely related) substance with the
intention of relieving or avoiding withdrawal symptoms;

Evidence of tolerance, such that increased doses of the psychoactive
substance are required in order to achieve effects originally produced by lower
doses;

Progressive neglect of alternative pleasures or interests because of
psychoactive substance use, increased amount of time necessary to obtain or
take the substance or to recover from its effects;

Persisting with substance use despite clear evidence of overtly harmful
consequences, such as harm to the liver through excessive drinking, depressive
mood states after periods of heavy substance use, or drug-related impairment of
cognitive functioning; efforts should be made to determine that the user was
actually, or could be expected to be, aware of the nature and extent of the
harm.

The Expert Committee on Drug
Dependence (ECDD) concluded “there were no substantial inconsistencies
between the definitions of dependence by the ECDD and the definition of
dependence syndrome by the ICD-10.”

Diversion: The movement
of controlled drugs from licit to illicit distribution channels or to illicit
use.

Essential medicines:
Those medicines that are listed on the WHO Model List of Essential Medicines or
the WHO Model List of Essential Medicines for Children. Both model lists
present a list of minimum medicine needs for a basic healthcare system, listing
the most efficacious, safe, and cost-effective medicines for priority
conditions.

Feldshersko-akusherski punkt(FAP): A local health clinic that provides basic procedures, including
prenatal care and first aid. These health centers are run by feldshers,
physician assistants trained in vocational medical schools. They provide
routine checkups, immunizations, emergency first-aid, and midwifery services.
There are no physicians at these clinics.

Life-limiting illness: A
broad range of conditions including cancer, HIV/AIDS, dementia, heart, renal,
and liver disease, and permanent serious injury, in which painful or
distressing symptoms occur; although there may also be periods of healthy
activity, there is usually at least a possibility of premature death.

Misuse (of a controlled
substance): Defined in this report as the non-medical and non-scientific use of
substances controlled under the international drug control treaties or national
law.

Morphine: A strong opioid
medicine that is the cornerstone for treatment of moderate to severe cancer
pain. The WHO considers morphine an essential medicine in its injectable,
tablet, and oral solution formulations.

Narcotic drugs: A legal
term that refers to all those substances listed in the Single Convention.

Opioid: The term means
literally “opium-like substance.” It can be used in different
contexts with different but overlapping meanings. In pharmacology, it refers to
chemical substances that have similar pharmacological activity as morphine and
codeine, i.e. analgesic properties. They can stem from the poppy plant, be
synthetic, or even made by the body (endorphins).

Palliative care: Health
care that aims to improve the quality of life of people facing life-limiting
illness, through pain and symptom relief and psychosocial support for patients
and their families. Palliative care can be delivered in parallel with curative
treatment but its purpose is to care, not cure.

Psychosocial support: A
broad range of services for patients and their families to address the social
and psychological issues they face due to life-limiting illness. Psychologists,
counselors, and social workers often provide these services.

Strong opioid analgesics:
Pain medicines that contain strong opioids, such as morphine, methadone,
fentanyl, and oxycodone and are used to treat moderate to severe pain.

Weak opioid analgesics:
Pain medicines that are generally used to treat mild to moderate pain,
including codeine, dihydrocodeine, and tramadol.

Prologue: The Story of Vlad Zhukovsky

Born in 1983, Vladislav (Vlad) was in many ways a young
Ukrainian no different than many others. He lived with his mother and sister in
a two-bedroom flat in a Soviet-style apartment park on the outskirts of Cherkassy
in central Ukraine. He loved playing his guitar and taking walks along the River
Dnepr. He faithfully attended church with a tight knit group of friends and had
a knack for computers, a talent he hoped to turn into a career.

Vlad’s ordinary life abruptly ended in 2001 when he
was a second-year student of computer technology. One day in class, he
developed a headache that was so severe that, according to his mother, he fell
down, crying in pain. “We gave him analgin [a commonly used pain medication]
but nothing worked,” said Nadezhda (Nadya), Vlad’s mother. “He
just grabbed his head and screamed.”[2] She
called an ambulance to take Vlad to the hospital, where brain scans revealed a
large medulloblastoma of the cerebellum, a malignant tumor.

A fierce battle with cancer ensued. Radiation initially
forced the brain tumor into remission. But the cancer kept coming back. Over
the next nine years, tumors formed in Vlad’s lower spine, again in his
head, his chest, and eventually again his spine. With each new tumor, the
periods of remission grew shorter and Vlad weaker.

Throughout this ordeal, Vlad and his mother fought a second
battle: with pain. This battle, at least, should not have been a losing one.
The World Health Organization (WHO) says that “[m]ost, if not all, pain
due to cancer could be relieved if we implemented existing
medical knowledge and treatments.”[3] But as
Vlad learned, the way Ukraine’s healthcare system treats cancer pain has
little in common with current medical knowledge.

In 2007 Vlad developed persistent, severe pain that
over-the-counter pain medicines could no longer relieve. According to his
mother, who devotedly took care of her son, the pain was so bad that he often
screamed in agony, sometimes so loud that it disturbed their neighbors. She
told Human Rights Watch: “Hearing his pain, how he struggled, how
he howled, it was just impossible to be in the [same] room.” The pain
deprived him of sleep, made him moody, disrupted normal interaction with family
and friends, and—possibly worst of all for a young man who liked to be
active—reduced him to passively lying in bed and staring at the ceiling.
Indeed, the pain incapacitated Vlad more than his cancer.

While Vlad’s doctors
did prescribe a strong pain medication to treat Vlad’s pain, they did so
with inadequate regularity and insufficient doses to offer full relief. The WHO
recommends that morphine or a pain medication of similar strength be given
every four hours to ensure continuous relief and that “the
‘right’ dose is the dose that relieves the patient’s
pain.”[4] Yet, Vlad’s doctors initially prescribed just three doses per day,
leaving him without relief half of the time.

One day, in June 2008, Vlad’s pain became so severe that
he could no longer bear it and decided to jump from his hospital window. While
his mother was pleading with nurses to give him more pain medications, Vlad climbed
into the open window. Most of his body was already outside—his fall imminent—when
his roommate, a retired police officer, noticed what was happening, grabbed him
by the leg, and forced him back in. He later told his mother that he had wanted
to fall “head down and be dead right away so it wouldn’t hurt
anymore.” Vlad, who was very religious, was deeply troubled by his
suicide attempt. He repeatedly told his mother afterwards that he worried that
the pain might make him do something sinful that would prevent him from seeing
her again in heaven.

No matter how obvious it was that Vlad’s pain was not
under control, doctors met Nadya’s subsequent pleas for more pain
medications with great reluctance, sometimes bordering on hostility. When she pleaded
for a fourth dose, doctors at one hospital accused her of selling the medications
on the street. A year later, as she tried to convince doctors at another
hospital that her son needed a fifth dose, doctors claimed more of the
medication would lead to an overdose and they would then face prosecution
“like Michael Jackson’s doctor.”

Supported by his mother and a small, local nongovernmental
palliative care organization called Face-to-Face, Vlad battled with the pain
and the cancer. He tried to stay positive and enjoy those moments when he was
not in pain. Even after the cancer invaded his spinal cord and paralyzed him
from the waist down, his church friends would occasionally take him in a
wheelchair to the River Dnepr for a short walk.

Vlad died in October 2010. A few months before his death, he
said he hoped to be remembered as “an ordinary, happy person, as normal,
sociable Vlad.”[5]

During this nine year ordeal, Vlad and his mother frequently
spoke of the need for change in Ukraine’s healthcare system that caused
him so much unnecessary suffering. Vlad did not want his agony to be in vain or
suffered again by tens of thousands of Ukrainians battling cancer each year.

***

This report is dedicated to Vlad’s courage and memory,
and to his mother Nadya.

Summary

Patients with life-limiting illnesses need curative
treatment, but they also need palliative care, which aims to address pain and
improve life quality diminished by debilitating symptoms such as shortness of
breath, anxiety, and depression.[6]

Every year almost half a million people in Ukraine may require
palliative care services to alleviate the symptoms of life-limiting illnesses.[7]
These include circulatory system illnesses such as chronic heart disease (almost
489,000 deaths per year), cancer (100,000), respiratory illnesses (28,000),
tuberculosis (10,000), neurological disorders such as Alzheimer’s disease
(6,500), and HIV and AIDS (about 2,500).[8]

Relieving pain is a critical part of palliative care. About
80 percent of patients with advanced cancer develop moderate to severe pain, as
do significant numbers of patients with HIV and other life-limiting illnesses.
With existing medical knowledge physical pain can be successfully treated in
most cases. But while these symptoms are treatable, limitations in Ukraine’s
health policy, education, and drug availability; lack of cohesion, urgency, and
coordination on the part of the government; unnecessarily onerous drug
regulations; inadequate training and a dearth of exposure to palliative care
services for Ukrainian healthcare providers mean the country’s public
health system offers poor pain treatment and little support for families
dealing with life-limiting illnesses.

The country has 9 hospices with a total of about 650 beds,
which provide services to inpatients.[9] The
government has also assigned palliative care beds in some other public
hospitals, and the national cancer control plan envisions a total of 36
hospices by 2016, although it does not allocate a budget for this.[10]
Despite this, most patients with life-limiting illnesses in Ukraine die at home;
indeed, hospitals are not supposed to admit patients with cancer who are no
longer receiving curative treatment. Yet there are no full-fledged home-based
palliative care services.[11]
Some nongovernmental organizations (NGOs) provide home-based care but cannot
offer pain management with opioid analgesics, including morphine, which WHO
guidelines for cancer pain emphasize, should be used to treat moderate to
severe pain. Most AIDS centers do not offer palliative care services.[12]
According to a 2011 International Narcotics Control Board (INCB) report, the
amount of opioid analgesics Ukraine uses per year is “very
inadequate.”[13]

In 2010 Human Rights Watch—together with the Institute
of Legal Research and Strategies in Kharkiv and the Rivne and Kiev branches of
the All-Ukrainian Network of People Living with HIV—researched the
availability of pain treatment and palliative care in Ukraine. We found that
Vlad’s unnecessary suffering was not an unfortunate anomaly. Rather, it
was in many ways representative of the fate of patients who endure pain due to
life-limiting diseases.

In dozens of interviews, patients, families, doctors,
nurses, and government officials painted a picture of a healthcare system that
systematically fails patients who are in severe pain because pain treatment is
often inaccessible, best practices for palliative care are ignored, and
anti-drug abuse regulations hamstring healthcare workers’ ability to
deliver evidence-based care. Those healthcare workers who try to provide the
most effective pain treatment possible must often operate, as one oncologist
said, “on the edge of the law.”[14] These doctors
and nurses ignore legal restrictions and provide patients with a take-home
supply of strong pain medications or leave the day’s supply with patients
to administer themselves. In doing so, these doctors and nurses expose
themselves to administrative and criminal charges for putting patients’
well-being first.

The situation is particularly devastating in rural areas—home
to about one-third of Ukraine’s population of 46 million—where
strong opioid analgesics are often hard to access or simply unavailable.[15]
Only central district hospitals have the necessary license to stock and dispense
morphine and other strong opioid analgesics, according to doctors in rural
districts who said requirements for obtaining such licenses are too onerous and
costly for many smaller hospitals and health clinics.[16]
As a result, people in rural towns and villages often live far from health centers
with strong pain medications.

Distance might be
surmountable if healthcare providers could give patients and their families a
supply of strong opioid analgesics for at least a week or two. However, under
Ukraine’s drug regulations healthcare workers must directly administer
injectable strong opioid pain medications to patients, a requirement that is
medically unnecessary. As oral morphine is unavailable in Ukraine, a nurse or
other healthcare worker must travel to the patient’s home up to six times
a day to administer pain medications (the WHO recommends that morphine is
administered every four hours). This burden is too great for healthcare
workers, leaving patients with severe pain in remote areas
“doomed,” according to one nurse.[17]

Patients in urban areas face a different problem. Here,
hospitals generally do have the license for strong opioid analgesics, but pain
treatment is still often woefully inadequate, as healthcare workers routinely
ignore the core principles for effective pain treatment that the World Health
Organization has identified.[18] This
leaves individuals with inadequate and inconsistent relief from excruciating
pain.

There is no acceptable
reason why Ukraine cannot deliver proper palliative care and pain management to
patients with life-limiting illnesses. Although under-resourced, Ukraine has a
healthcare system that is able to deliver effective treatment for various other
health conditions.

Failure to address barriers to effective pain treatment
identified in this report places Ukraine in violation of the right to health
guaranteed by the International Covenant on Economic, Social and Cultural
Rights (ICESCR), and in possible violation of the prohibition on torture and
cruel, inhuman, or degrading treatment. It also ensures that Ukraine continues
to remain out of step with its neighbors—including Belarus, Moldova,
Russia, and Turkey–which have less restrictive drug regulations and with
European countries that all (except for Armenia and Azerbaijan) have oral
morphine available for patients.[19] Lack of
action also means that Ukraine will continue to deviate fundamentally from
World Health Organization recommendations in standard pain treatment practices,
that healthcare workers will have to break the law to provide evidence-based
care, and that patients will continue to suffer.

All medical students
should receive basic instruction on palliative care and pain treatment. Those
specializing in disciplines that frequently care for people with life-limiting
illnesses should receive detailed instruction and exposure to clinical
practice. Ukraine must urgently amend the restrictive and problematic licensing
requirements for healthcare
institutions and workers to stock, prescribe, or dispense opioid analgesics and
must simplify the prescribing procedure that currently creates a barrier to
timely treatment with morphine for patients with pain. Problematic dispensing
procedures should be revised, and the current complex and wasteful record
keeping system improved. Inspections of healthcare institutions that work with
opioid analgesics should be conducted so as to minimize their impact on the
provision of and access to medical care, and Ukraine’s criminal code should
be amended to differentiate between intentional and unintentional violations of
the rules of handling opioid medications.

***

Our research found that when strong opioid analgesics are
available, they are provided in a way that fundamentally deviates from WHO
recommendations, with each of the five core principles it has identified
routinely ignored.[20]

Principle 1: Pain medications should be given orally whenever possible. If a patient
cannot take medications by mouth, rectal suppositories, or under-the-skin
injections should be used.In Ukraine no oral morphine is
available. Doctors use only injectable strong opioids for pain treatment.
Instead of injecting morphine under the skin, as the WHO recommends, injections
are given into muscles. This results in large numbers of unnecessary
intramuscular injections, which are unpleasant for patients and carry a risk of
infection. Throughout the three years he was on strong pain medications, Vlad
received thousands of unnecessary injections with pain medications. His mother
compared his bottom, where most of the injections were administered, to a
“mine field.”

Principle
2: Pain medications should be given every four hours to ensure continuous pain
control.While the WHO recommends that patients receive strong
pain medications every four hours, most patients in Ukraine get them only once
or twice per day. As the effects of morphine last for four to six hours, this
means that such patients are without adequate relief for most of the day. While
doctors prescribe weaker pain medicines and other medications for the
intervals, these are not potent enough to provide effective relief and expose
patients to unnecessary side effects. Our research suggests this practice is
largely due to the requirement in Ukrainian law that healthcare providers
directly administer injectable strong opioid analgesics to patients. Doctors at
various health facilities told us that they do not have the resources for a
nurse to visit patients at home six times per day.

Principle
3: The type of pain medication (basic pain reliever, weak opioid, or strong
opioid) should depend on severity of pain. If a pain medication stops providing
effective relief, a stronger medication should be used. International
research suggests that about 80 percent of terminal cancer patients need a
strong opioid pain medicine for an average period of 90 days before death.[21]
Yet figures we received from various hospitals in Ukraine about the percentage
of cancer patients who receive morphine or other strong opioid analgesics and
the average number of days patients receive them suggest that many patients are
started on strong opioid analgesics late, if at all. In the six hospitals and
one polyclinic department of a city hospital for which we received such data,
we found that in the best case only about one-third of terminal cancer patients
received a strong opioid analgesic—in most cases it was far less—and
in some cases for far less than 90 days.

Principle
4: The dose of medication should be determined individually. There is no
maximum dose for strong opioid pain medications. While the WHO
treatment guideline specifically states there should be no maximum daily dose
for morphine, both Ukraine’s Ministry of Health and the Zdorovye Narodu pharmaceutical
company, the only manufacturer of morphine in Ukraine, recommend a maximum
daily dose of 50 mg of injectable morphine. This dose is far below levels of
morphine used safely and effectively for the treatment of severe pain in other
countries. We found that many doctors in Ukraine, though not all, adhere to the
recommendation and cap the dose even when the patient is still in pain.

Principle
5: Pain treatment should be delivered according to the patient’s needs. Because nurses have to come to patients’ homes to administer morphine
injections, it is not the patient’s schedule but that of the healthcare
worker that determines when the patient receives his medications. As a result,
patients wait in agony for nurses to arrive or do not need the medicine when
the nurse is present.

While our research focused mostly on the plight of cancer
patients, we also documented a number of cases of people who had severe pain
due to other diseases or health conditions. We found that these patients face
even greater challenges in getting access to good pain treatment. General
practitioners and other specialists are rarely trained in treating pain and
often worry about prescribing strong opioid medications to non-cancer patients.
Several patients with non-cancer pain told us that their doctors ignored their
complaints about pain or told them it would simply go away by itself once the
cause had been treated.

***

Three areas—health
policy, education, and drug availability—contribute to the limited
availability of palliative care and pain treatment in Ukraine. The World Health
Organization sees each of these three areas as fundamental to the development
of palliative care and pain management services and has urged countries to take
action in each, observing that measures in each area cost little but can
significantly impact the availability of palliative care.[22]

Health Policy The WHO has recognized palliative care as an integral and essential part
of comprehensive care for cancer, HIV/AIDS, and other health conditions and
recommends that countries establish a national palliative care policy or
program.[23] While the Ukrainian government has established the
Institute of Palliative and Hospice Medicine in the Ministry of Health and
created a number of hospices and palliative care beds, no national palliative
care policy exists at this time and the government has not undertaken a
coordinated effort to address barriers to palliative care. The
government’s failure to address critical issues like the lack of oral
morphine and the need to develop home-based palliative care are particularly
problematic.

Education The World Health Organization recommends that countries adequately instruct
healthcare workers on palliative care and pain treatment.[24]
Yet in Ukraine official curricula for undergraduate and postgraduate medical
studies do not provide any specific education on palliative care and pain
management. The WHO cancer pain treatment guideline is barely taught in medical
or nursing schools, if it is taught at all. Many healthcare workers interviewed
did not understand the basic principles of pain management and palliative care.

Drug
availability The WHO recommends that countries establish a
rational drug policy that ensures availability and accessibility of essential
medicines, including morphine. Under the UN drug conventions countries must
ensure adequate availability of opioids for medical purposes while also
preventing their misuse.[25]
However, Ukraine’s primary focus has been to prevent misuse of these
medications. Human Rights Watch recognizes that such prevention is particularly
important in countries that, like Ukraine, face major problems with illicit
drug use—the country is home to an estimated 230,000 to 360,000 injecting
drug users—and corruption in the healthcare sector.[26]
But these efforts should not interfere with adequate availability of controlled
substances for legitimate, medical purposes.

Ukraine’s drug regulations are far more restrictive
than required under the UN drug conventions and contain numerous provisions
that directly interfere with the delivery of good pain care, discourage doctors
from prescribing opioid medications due to excessively burdensome bureaucratic
requirements, and generate fear among doctors of the legal repercussions of
prescribing these medications.

To its credit, Ukraine’s government recognizes the
need for reform to ensure effective pain treatment and palliative care
services. It has established the Institute of Palliative and Hospice Medicines in
the Ministry of health, created hundreds of hospice beds, and removed some
problematic provisions from its drug regulations in 2010.[27]
In an October 2010 meeting with Human Rights Watch the then head of the
National Drug Control Committee expressed concern about the lack of narcotics
licenses at pharmacies in rural areas and said his committee was exploring
solutions.[28]

***

Under the International Covenant on Economic, Social and
Cultural Rights, the Ukrainian government is obligated to take steps “to
the maximum of its available resources” to progressively realize the
right to health. In keeping with this, the government should formulate a plan
for the development and implementation of palliative care services, ensure the
availability and accessibility of morphine and other medications that the World
Health Organization considers essential, and ensure that healthcare providers
receive training in palliative care. The Ukrainian government’s failure
to do so violates the right to health.

Under the prohibition of torture and ill-treatment, the
Ukrainian government has an obligation to take steps to protect people under
its jurisdiction from inhuman or degrading treatment, such as unnecessary
suffering from extreme pain. As the UN special rapporteur on torture and other
cruel, inhuman or degrading treatment or punishment has noted, “failure
of governments to take reasonable measures to ensure accessibility of pain treatment
… raises questions whether they have adequately discharged this
obligation.”[29] The fact that public
healthcare facilities in Ukraine offer pain treatment in a way that
fundamentally deviates from well-established international best practices and
that the government has not taken steps to change this calls into question
whether the government has fulfilled this obligation. It may thus be liable
under the prohibition of torture and cruel, inhuman, or degrading treatment.

This report focuses specifically on the poor availability of
palliative care services in Ukraine. Human Rights Watch fully recognizes the
problems that exist with availability and accessibility of other health
services in Ukraine. The fact that this report focuses on a specific area of
healthcare does not suggest that government authorities in Ukraine do not have
an obligation under international human rights law to take reasonable steps to
address problems in other parts of the healthcare system.

Key Recommendations

To the Government of Ukraine:

Ensure the availability of oral morphine throughout the public
healthcare system.

Amend licensing provisions of drug regulations to ensure that all
rural healthcare clinics and hospitals can obtain licenses for strong opioid
analgesics.

Amend drug regulations to ensure that patients or their relatives
can receive a reasonable take-home supply of strong opioid analgesics that
realistically enables them to enjoy continuous pain relief.

Disseminate WHO pain treatment guidelines to all healthcare
facilities and roll out in-service training for all oncologists and other
relevant healthcare workers.

In consultation with all relevant stakeholders, develop an
action plan to ensure access to palliative care and pain management nationwide
that provides for:

Developing a national palliative care and pain treatment
guideline, consistent with international best practices.

Introducing instruction on internationally recognized pain
treatment best practices in all medical and nursing schools and as part of
continued medical education programs.

A review process for Ukraine’s drug regulations aimed at
ensuring adequate availability and accessibility of strong opioid medications
for medical use while preventing their misuse.

To the Zdorovye Narodu Pharmaceutical Company:

Amend product information for injectable morphine to bring it in
line with available evidence.

Start manufacturing oral morphine.

To the International Community:

Raise concern with the government of Ukraine about the limited
availability of quality palliative care and pain treatment services.

Offer technical and financial assistance to implement the
recommendations contained in this report.

Methodology

This report is based on research conducted between March
2010 and 2011, including field visits to Ukraine in April and October 2010.
Field research was conducted primarily in the Kharkiv and Rivne provinces and
in Kiev. Research in these provinces and Kiev was conducted jointly with the
Institute of Legal Research and Strategies in Kharkiv and the Rivne and Kiev
branches of the All-Ukrainian Network of People Living with HIV. We chose these
locations for research because of their geographic diversity. Additional
research was conducted in the cities of Lviv and Cherkassy. We also conducted
desk research regarding palliative care availability in various other parts of
the country.

During four weeks in Ukraine a researcher from Human
Rights Watch and each partner organizations conducted more than 67 interviews
with a wide variety of stakeholders, including 20 people with cancer, HIV/AIDS,
and other life-limiting health conditions, or their relatives; 35 healthcare
workers, including oncologists, AIDS doctors, anesthesiologists, palliative
care doctors, and administrators of hospitals, hospices, and palliative care
programs; and a dozen drug control and health officials.

Most interviews with patients and their relatives were
conducted at their homes. Interviews were conducted in private.

Interviews were semi-structured and covered a range of
topics related to palliative care and pain treatment. Before each interview we
informed interviewees of its purpose, informed them of the kinds of issues that
would be covered, and asked whether they wanted to participate. We informed
them that they could discontinue the interview at any time or decline to answer
any specific questions without consequence. No incentives were offered or
provided to persons interviewed.

We have disguised the identities of all patients, relatives,
and healthcare workers interviewed to protect their privacy, except when they
specifically asked for their identity to be used. Similarly, we have disguised
the names of the districts we visited to protect healthcare workers who, as
government employees, may have legitimate concerns about a possible negative
official response to their speaking out about problems with pain treatment.

All interviews were conducted in Russian by the Human Rights
Watch researcher, a fluent Russian speaker. Most interviewees had no difficulty
speaking Russian. Researchers from partner organizations provided translation
where necessary.

In October 2010 Human Rights Watch presented preliminary
findings to the Ministry of Health, the National Drug Control Committee, the
section for the licit circulation of narcotic drugs of the Ministry of
Interior, and the State Expert Center of the Ministry of Health. In March 2011,
Human Rights Watch wrote a detailed letter summarizing the report’s
findings to the pharmaceutical company Zdorovye Narodu, inviting it to respond
to the findings and to present comments in this report. A copy of the letter is
included in this report in Annex 1. No response had been received by the time
the report went to print in late April 2011.

All documents cited in the report are publicly available or
on file with Human Rights Watch.

I. Overview: Palliative Care and Pain Treatment

Palliative care seeks to improve the quality of life of
patients facing life-limiting or terminal illness. Its purpose is not to cure a
patient or extend his or her life. Palliative care prevents and relieves pain
and other physical and psychosocial problems, “adding life to the days,
not days to the life,” in the much-quoted words of Dame Cicely Saunders,
founder of the first modern hospice. The World Health Organization recognizes
palliative care as an integral part of healthcare that should be available to
those who need it.[30] While palliative care is
often associated with cancer, a much wider circle of patients with health
conditions can benefit from it, including patients in advanced stages of
neurological disorders, cardiac, liver, or renal disease or chronic and
debilitating injuries.

One key objective of
palliative care is to offer patients treatment for their pain. Chronic pain is
a common symptom of cancer and HIV/AIDS, as well as other health conditions.[31]Research consistently finds that 60 to 90 percent
of patients with advanced cancer experience moderate to severe pain.[32] Prevalence and severity of pain usually increase
with disease progression: several researchers have reported that up to 80
percent of patients in advanced stages of cancer experience significant pain.[33] Pain symptoms are a problem for a significant
proportion of people living with HIV as well, even as the increasing
availability of antiretroviral drugs in middle and low-income countries
prolongs lives.[34] With the advent of antiretroviral therapy (ART),
the international AIDS community has understandably focused on treatment for
people living with HIV. Unfortunately, this has led to a widespread but
incorrect perception that these people no longer needed palliative care. In
fact, various studies have shown that a considerable percentage of people on
ART continue to experience pain and other symptoms that improve with
simultaneous delivery of palliative care and ART.[35]

Moderate to severe pain
profoundly impacts quality of life. Persistent pain has a series of physical,
psychological, and social consequences. It can lead to reduced mobility and
consequent loss of strength; compromise the immune system; and interfere with a
person’s ability to eat, concentrate, sleep, or interact with others.[36] A WHO study found that people who live with
chronic pain are four times more likely to suffer from depression or anxiety.[37] The physical effect of chronic pain and the
psychological strain it causes can even influence the course of disease, as the
WHO notes in its cancer control guidelines, “Pain can kill.”[38] Social consequences include the inability to
work, care for oneself, children, or other family members, participate in
social activities, and find emotional and spiritual closure at the end of life.[39]

According to the WHO, “Most, if not all, pain due to
cancer could be relieved if we implemented existing medical
knowledge and treatments” (original emphasis).[40]
The mainstay medication for treating moderate to severe pain is morphine, an
inexpensive opioid made of poppy plant extract. Morphine can be injected, taken
orally, delivered through an IV, or into the spinal cord. It is mostly injected
to treat acute pain, generally in hospital settings. Oral morphine is the drug
of choice for chronic cancer pain and can be taken both in institutional
settings and at home. Morphine is a controlled medication, meaning that its
manufacture, distribution, and dispensing is strictly regulated at both
international and national levels.

Medical experts have recognized the importance of opioid
pain relievers for decades. The 1961 Single Convention on Narcotic Drugs, the
international treaty governing use of narcotic drugs, explicitly states that
“the medical use of narcotic drugs continues to be indispensable for the
relief of pain and suffering” and that “adequate provision must be
made to ensure the availability of narcotic drugs for such purposes.”[41]
The WHO includes both morphine and codeine (a weak opioid) in its Model List of
Essential Medicines, a roster of the minimum essential medications that should
be available to all persons who need them.[42]

Yet, approximately 80 percent of the world’s population
has either no, or insufficient, access to treatment for moderate to severe pain
and tens of millions of people around the world— including around 5.5
million cancer patients and 1 million end-stage HIV/AIDS patients—suffer
from moderate to severe pain each year without treatment.[43]

But palliative care is broader than just relief of physical
pain. Other key objectives may include provision of care for other physical
symptoms and psychosocial and spiritual care for patients and family members
who face life-threatening or incurable and often debilitating illness. Anxiety
and depression are common symptoms.[44] Palliative
care interventions like psychosocial counseling have been shown to considerably
diminish incidence and severity of such symptoms and to improve the quality of
life of patients and their families.[45]

Palliative care also seeks to alleviate other physical
symptoms, such as nausea and shortness of breath, which are frequently
associated with life-limiting illness and significantly impact a
patient’s quality of life.

The WHO has urged countries, including those with limited
resources, to make palliative care services available. It recommends that
countries prioritize implementing palliative care services in the
community—providing care in medical institutions that deal with large
numbers of patients requiring palliative care services and in people’s
homes rather than at healthcare institutions—where it can be provided at
low cost and where people with limited access to medical facilities can be
reached.[46]

The Story of Konstantin Zvarich

Konstantin, a 67-year-old pensioner from Poltava province in
central Ukraine, was in many ways a typical Ukrainian from the countryside.
Born in 1943, he grew up amid the hunger and devastation caused by World War
II. As a young man, he served in the Soviet army before joining a collective
farm, where he worked for 46 years. Konstantin was married, had a daughter, and
a grandson.

Konstantin developed problems urinating in January 2009.
When the pain became so severe he could no longer pass urine, he went to the
local clinic where a doctor diagnosed prostate cancer. Two rounds of surgery
provided temporary relief from the pain but were unable to remove all the
cancerous cells which soon began to metastasize.

A sudden onset of intense pain in his hands and fingers alerted
Konstantin that all was not right. He had further tests which revealed the
cancer had spread to his bones, a condition often associated with severe pain. Konstantin
told Human Rights Watch:

The pain was so bad that my whole body seemed to break. We
would call the ambulance every two to three hours because I could not stand it.[47]

Doctors briefly hospitalized Konstantin and then sent him home
with a prescription for tramadol, a weak opioid pain medication. Because few
pharmacies in Ukraine stock tramadol—the result of the government’s
2008 decision to treat tramadol essentially like morphine—Konstantin’s
relatives had significant difficulty obtaining the medication. When Konstantin
was finally able to get tramadol, it turned out to be far too weak to control his
excruciating pain. He used all ten ampoules of tramadol—the maximum allowed
under Ukrainian law per prescription—in a day without bringing his pain under
control.

Konstantin’s daughter, a medical doctor in Kharkiv, a
city in eastern Ukraine, advised him to take a variety of over-the-counter pain
medications, none of which provided much relief. Although he complained to his
doctors of severe pain, Konstantin’s doctors never prescribed morphine. The
local clinic did not have the necessary license. (See Chapter III for detail on
licensing requirements and procedures.) For four or five months Konstantin
suffered ongoing, severe pain. Describing one particular episode, he broke down
in tears saying:

It was unbearable. I
came home and the pain grabbed me so strongly. It was so bad that I
didn’t know what to do with myself. It is so difficult to live like this.[48]

One day in late summer, Konstantin’s pain was so bad
that his grandson, who was staying with him in the village, called his mother,
telling her that his grandfather was “bouncing of the walls” from
pain. The daughter decided she could no longer leave her father in the village
and managed to arrange a bed for him at Kharkiv’s hospice. There, Konstantin
finally received morphine for his pain. When Human Rights Watch interviewed him
in April 2010, he said that his pain was finally under control at the hospice.

Konstantin died in June 2010 at the hospice.

Lack of Narcotics Licenses at Health Clinics and
Pharmacies

Tens of thousands of patients with pain across
Ukraine’s vast rural areas, where one-third of its population of
approximately 46 million people lives, face a similar fate to Konstantin’s
every year.

Local health clinics—known asambulatoria and feldshersko-akusherski
punkt (FAP)—and even many small hospitals do not have the narcotics
licenses necessary to stock and prescribe strong opioid analgesics.[49]
Even when patients receive a prescription, few pharmacies in rural areas are
licensed to fill prescriptions for opioid medications. Although most of these
facilities could apply for a license, Ukraine’s drug regulations require
that they have a separate room to store these medications, which is specially
equipped to prevent break-ins and theft. The associated cost and lack of spare
rooms are the main reasons that few health clinics and small hospitals obtain
narcotics licenses.

During its research, Human Rights Watch and local partners
visited the main hospitals in five districts in Kharkiv and Rivne provinces, in
eastern and western Ukraine respectively. Known as central district hospitals,
these are the main health facilities and administrative centers for the public
healthcare system in their districts. While all the central district hospitals
had narcotics licenses, doctors at each location told us that none of the
clinics did. As Table 1 shows, this means that many patients live dozens of
kilometers away from health facilities that are authorized to prescribe strong
pain medications, even if their own village or town has a health facility. A
health official in Rivne province told us that the same was true for all other
districts in the province: all 15 central district hospitals have the license
but none of the 92 ambulatorias or the 613 FAPs in the province do.

A Broken Pain Treatment Delivery System

The lack of licensed health facilities in rural areas means
that patients or their relatives have to travel long distances to fill
prescriptions for strong pain medications, often on poor roads and infrequent
public transport. This already problematic situation is exacerbated by a pain
treatment delivery system that does not allow clinics to provide patients and
their relatives with a take-home supply of injectable morphine.

In general, doctors do not write prescriptions for strong
opioid analgesics for patients to fill at pharmacies. Instead, patients receive
morphine from hospital stock. While this has the advantage that patients do not
have to pay for their medications, Ukraine’s drug regulations require
healthcare workers to administer injectable strong opioid analgesics from
hospital stock directly to the patient.[57] In
other words, health facilities are not allowed to give the medication to
patients or their relatives to take home and administer themselves. Instead,
healthcare workers are supposed to visit patients at their homes for every
prescribed dose of injectable morphine, often multiple times per day. The
regulations do allow self-administration of oral opioid analgesics but none are
available in Ukraine due to a lack of effort by the government to offer them
through the public healthcare system.

This system is a major barrier to evidence-based pain care
in Ukraine’s urban areas and often an insurmountable obstacle in rural
areas, where healthcare facilities lack the resources for staff to travel to
central district hospitals to pick up strong pain medications and then visit
patients at home several times per day. As a result, many patients end up
without access to the pain medications they need. Some patients may get pain
medications once or twice per day. And only a very few—those who live in
districts where doctors are willing to ignore government
regulations—might get reasonably effective pain treatment.

In each of the five
districts visited for this research, we found that healthcare providers
struggled to deliver strong pain medications to patients. Their approaches (Table
2) varied from not providing strong opioid analgesics to patients outside
district centers to trying to accommodate them. But even in the best scenario
major and unnecessary obstacles remained to evidence-based pain care. In each
district, doctors and nurses openly admitted that many patients, particularly
those who live outside the district centers, were not getting the care they
needed.

TABLE 2

Districts

Approach to
delivering pain treatment

Districts 1, 2, 5, 6

Nurses
from the central district hospital are responsible for delivering injections
with pain medications during the day to patients who live in the district
center; ambulances administer the injections during evening hours. Nurses and
feldshers from local health clinics are responsible for delivering pain
treatment to patients outside the district center.[58] They have to travel
to the central district hospital every day to pick up the daily supply of
medications for their patients and then visit them at their homes for each
injection. Ambulances do not provide pain care outside the district center.

District 3

Ambulances
are responsible for delivering strong pain medications to all patients irrespective
of where they live and at any time of the day.

District 4

Healthcare
workers provide patients or their relatives with a three-day supply of
morphine and allow them to administer the medication themselves, in
contravention of Ukraine’s drug regulations. Every third day, in return
for the empty ampoules, patients or their relatives receive their medications
for the next three days. Nurses and feldshers at local health clinics are
instructed to check in on patients regularly to ensure that they are using
the medications appropriately and are achieving adequate pain control.

In districts 1, 2, 5,
and 6, patients living outside the district center often had no access to
strong opioid analgesics. The oncologist in district 2 expressed his
frustration with the system:

Prescribing is not the issue; it’s delivering the
medications. If possible, injections are done daily. If the area is close, the
nurse can come every day to pick up morphine. They may come in the car of the
FAP or ambulatoria and return the empty ampoules the next day. But not all FAP
and ambulatoria have cars or they don’t have money for gas … If
people live far away, the reality is that we make do with tramadol [a weak
opioid] and dimedrol [an antihistamine]. We try the best we can. It is a tragedy
for such patients. I look at them and I want to do something for them but I
can’t.[59]

He added there were currently 30 end-stage cancer patients
in his district, 20 of whom should have been receiving strong opioid analgesics.
Instead, only three were.

The oncologist in
district 5 said it was problematic for nurses and feldshers to travel to the
central district hospital: “The rural healthcare system is poorly funded
so they [nurses and feldshers] talk to the relatives who pay for their travel
or bring the feldsher in their own cars.”[60] A nurse in district 1 said that staff at health
clinics in her district cannot travel to the central district hospital to pick
up morphine due to lack of transportation and time.[61] She took us to the house of a cancer patient who
had been prescribed one injection of morphine per day, which was delivered via an
ambulance that drove to his house every evening. The patient said he was in
significant pain during the day and that “it would be very good to have a
second injection. They make me feel so much better.”[62] The nurse said this was unlikely to happen:

If they prescribe an injection during the day, I will have
to go to the patient’s home myself. That would mean that when I come to
work at 8 a.m. I would pick up the ampoule from the chief nurse and then to
walk to the patient’s home because there is no transportation. That takes
30 to 40 minutes. I would do the injection and then have to walk back. So it
takes more than an hour to do one injection. That’s why we try not to prescribe
during the day.[63]

Poland’s Rural Areas: A Different Story

In Poland, morphine and other strong opioid analgesics
are readily available in rural areas. Oral morphine is included in
Poland’s essential medicines list, and pharmacies and health clinics
are required to stock them. Although pharmacies may apply for a waiver to
this rule—and quite a few do for opioid medications—there is a dense
network of pharmacies with narcotics licenses throughout the country.

When a pharmacy does not have opioids in stock, it can
request them from a wholesaler and generally receive new supply within half a
day. Opioid medications are provided free of charge at pharmacies. Doctors
can prescribe a 30-day supply of oral morphine per prescription. The
prescription can be filled at any pharmacy that has a narcotics license.

Most patients in the district, she said, receive just one
injection of morphine per day at most, leaving them in pain for most of the
day. The nurse noted that occasionally patients get a second injection. She
could remember only one patient in her eight years at the hospital who received
three injections of morphine per day.[64]

Asked if they ever simply
gave ampoules, small glass vials that contain morphine, to patients or their
relatives to take home, healthcare workers in districts 1 and 2 said that they
never did because of the strict control over these medications. The nurse in
district 1 said: “The chief nurse [who is responsible for keeping
records] is very strict with narcotic drugs. She has to protect herself because
there can be an inspection anytime and if ampoules are missing she is in
trouble.”[65] The oncologist in district 5 said that she and her
colleagues sometimes provide patients from villages with a two or three-day
supply.[66]

In district 3, where
ambulances deliver pain medications to all patients, access to pain medications
is significantly better. However, the ambulance service is not able to visit
patients every four hours, so most receive two doses of morphine per day.[67] The chief doctor noted that poor weather—much
of Ukraine sees significant snowfall in winter—can undermine the delivery
of pain medications. He recalled difficulties during the winter of 2010 when
major snowfall made many roads inaccessible:

If there is no road [accessible] we drive to the farthest
point and then go on foot. But in some cases, getting to the village—not
to speak of the house—was impossible this winter. We would contact the
road service … We had three patients in [rural villages] and asked if
they could at least open up the roads there. So we didn’t leave them
without help. Of course we couldn’t stick to the timing of the
injections.[68]

In district 4, healthcare workers violate Ukraine’s
drug regulations—and potentially expose themselves to disciplinary and
criminal sanctions—to improve patients’ accessibility to strong
opioid analgesics. Here, patients and their relatives are responsible for
obtaining pain medications from the central district hospital themselves. This
gives them the option of getting more doses of the pain medications, and
flexibility to administer it when most convenient for them. But it also places
a significant burden on families who have to travel every three days to the
central district hospital to collect medications.

The deputy chief doctor
at the central district hospital recalled an elderly lady who had been coming
to the central district hospital every three days for the last 18 months to
pick up pain medications for her husband, a cancer patient. Even though there
is a health clinic a kilometer from her house, she has to travel 20 kilometers
every third day to the district center because the local clinic does not have a
narcotics license.[69] A nurse at the central district hospital recalled
a woman who had to leave her village at 4 a.m. every third day in order to
catch a minibus to the district center and be able to make it back home the
same day.[70]

Svitlana Bulanova told us of her sister’s plight
caring for her daughter, Irina, a young woman with cervical cancer. She said
that after Irina’s cancer had metastasized to her bones, she often
screamed in agony due to the pain. Her doctors prescribed morphine but their
local clinic did not have a narcotics license. So Irina’s parents had to
travel the 25 kilometers to the district center every third day on public
transport, a five-hour round trip that involved walking to the main road, waiting
for a mini-bus to the district center, walking to the central district hospital
to get the medications, and then repeating the journey on the way back.[71]

Pharmacies and Opioid
Analgesics

Pharmacies play a limited role in distributing strong opioid
analgesics to patients in Ukraine because most doctors prescribe these
medications from hospital stock. But they do play a significant role in distributing
tramadol, a weak opioid analgesic widely used in Ukraine.

Pharmacies must have a
narcotics license before they can stock and dispense medications like morphine
or tramadol. Yet, few pharmacies in rural areas have such licenses. The head of
Ukraine’s National Drug Control Committee, the government agency
responsible for issuing licenses, told Human Rights Watch in October 2010 that
in Kirovohradskaia province there were only four pharmacies with such a license
for 1.1 million people.[72] He said the situation in other provinces was
somewhat less extreme but still highly problematic.[73]

This means that patients
or their relatives often have to travel to district centers to fill their
prescriptions, encountering the same challenges as described above. The chief
doctor at the central district hospital in district 3, for example, said that
in his district there is not a single pharmacy with a narcotics license so
patients have to travel to the next district to fill prescriptions for
tramadol. The doctor noted that there are just two buses per day to the town,
making the trip very burdensome for people without their own transportation.

Ukraine’s drug
regulations impose a strict limit on the amount of medication that can be
prescribed per prescription. Table 3 shows the maximum amounts for several
medications commonly used in pain management. This means that the patient or
relatives have to obtain a new prescription every few days and then travel to
the licensed pharmacy to fill it.

III. Throughout Ukraine: Ensuring Quality
of Pain Treatment Services

The Story of Lyubov Klochkova

Lyubov, a woman in her mid-forties, was a tireless advocate
for health rights. In her native city in Western Ukraine, she set up and ran
successful health and legal service programs. But she spent much of her time
traveling around Ukraine, Russia, and other parts of the former Soviet Union to
share her expertise with others.

In 2008, as she was attending a conference, Lyubov suddenly
felt desperately ill. Back home, medical tests found metastatic cervical cancer
for which she was immediately treated. Several months later Lyubov returned to work;
doctors thought her cancer was in remission.

But in early 2009 it became clear that all was not well. Rarely
sick before, Lyubov now suffered colds that she could not seem to shake. By March
a problem urinating sent her back to her doctor. Examinations showed that her
cancer had recurred and that a tumor was blocking her kidney.

At around the same time Lyubov developed increasingly severe
pain. At first her doctors tried to treat it with over-the-counter drugs and
weak opioids that provided limited relief. Although her doctor recommended morphine
Lyubov was ambivalent. She was worried that her body would get used to the
medication and it would not be effective when she needed it most. A stoic
woman, she continued to work, taking taxis to meetings to avoid having to walk.
But by the end of May she had become too sick to leave the house.

With the pain now too great to bear, Lyubov agreed to take
morphine.[76]
“Why did I doubt for so long whether or not to start morphine?” she
said when she got her first dose.

But the relief did not last long. Her doctor had prescribed
one shot of morphine per day giving her relief for just about four hours. Over
the next few weeks, as Lyubov kept complaining of persistent pain, doctors
added an extra shot each week until she finally received five ampoules of
morphine per day. Every morning, a nurse would visit the apartment and, in
violation of Ukraine’s drug regulations, left the supply of morphine for
the day. Lyubov’s husband would administer the medication when she needed
it.

But five ampoules per day were not sufficient to control
Lyubov’s pain. Her relatives were forced to ration the medication for
when she needed it most. Lyubov would try to tolerate her pain. Her daughter
told Human Rights Watch:

The daily dose was sufficient at most for three [effective]
doses; in other words, for twelve hours. Because they brought us too little
morphine we tried to save most of it for the night. During the day, we gave her
drugs from the pharmacy and a minimal dose of morphine. Most of it we left for
the night.[77]

By the morning, the morphine would be finished and Lyubov
would anxiously wait for the nurse to come. Lyubov’s daughter said:

The nurse [normally] came at 10 or 11 a.m., but sometimes
she was late. Mama would slumber at night. By 8 a.m. she would sit up rigid [from
the pain] and wait for the nurse to [arrive with the morphine].[78]

A few weeks before her death Lyubov made an unpleasant
discovery: she had reached the maximum daily dose for morphine and her doctor would
not be able to prescribe any more ampoules. As Lyubov’s pain intensified
the five ampoules gave her less and less relief. Lyubov and her daughter left
no stone unturned trying to get a larger morphine dose:

We of course asked for a sixth ampoule. When they told us
that five was the maximum we tried to find out through [a palliative care
expert] whether that’s true, how that’s determined, and how we
could get more of the medicine. Unfortunately, nothing worked out. The doctors
said that they don’t have the right to prescribe more. We discussed it
with the oncologist, the gynecologist, with all of them. We tried to mobilize
everyone we could.[79]

But the doctors would not budge. Lyubov had to somehow make
do with an increasingly inadequate amount of morphine. For several weeks she
faced great suffering until, during her last few days, her kidneys could no longer
clear the morphine from her body and her pain seemed to subside. She died in
late July 2009.

Comparing Ukrainian Pain Treatment Practices with WHO
Principles

The WHO Cancer Pain Ladder, a treatment guideline first
published in 1986, is an authoritative summary of international best pain treatment
practices available.[80] Based
on a wealth of pain treatment research that spans decades, it has formed the
basis for cancer pain treatment in many countries around the world. It has also
been used successfully to treat other types of pain.[81]
The treatment guideline is organized around five core principles for treating
pain (see Table 4). The European Society for Medical Oncology (ESMO) and the
European Association of Palliative Care (EAPC) have also developed cancer pain
treatment guidelines, which follow these same core principles.[82]
If followed, WHO estimates, the ladder can result in good pain control for 70
to 90 percent of cancer patients.[83]

Our research has found that standard pain treatment
practices in Ukraine deviate fundamentally from World Health Organization
recommendations, with all five core principles articulated in the treatment
guideline widely ignored.

Under the right to health, governments must ensure that pain
treatment be not only available and accessible, but also that it be provided in
a way that is scientifically and medically appropriate and of good quality.[84]
This means that healthcare providers should provide pain management in a way
that is consistent with internationally recognized best practices. Governments,
in their turn, have to create conditions which allow healthcare providers to do
so.

Principle 1: Pain medications should be delivered
in oral form (tablets or syrup) when possible.

Patients
receive morphine by injection only.

Principle 2: Pain medications should be
given every four hours.

Most
patients receive morphine once or twice per day, in exceptional cases three
or four.

Principle 3: Morphine
should be started when weaker pain medications prove insufficient to control
pain.

Patients
are often started on morphine only when curative treatment is stopped,
irrespective of pain levels.

Principle 4: Morphine dose should be
determined individually. There is no maximum daily dose.

Patients are routinely injected with one ampoule of morphine at the
time, irrespective of whether this is too little or too much. Many Ukrainian
doctors observe a maximum daily dose of 50 mg of injectable morphine, even if
it is insufficient to control the patient’s pain.

Principle 5: Patients
should receive morphine at times convenient to them.

Administration
of morphine depends on work schedules of nurses.

Principle 1: “By Mouth”

If possible, analgesics should be given by mouth. Rectal
suppositories are useful in patients with dysphagia [difficulty swallowing],
uncontrolled vomiting or gastrointestinal obstruction. Continuous subcutaneous
infusion offers an alternative route in these situations. A number of
mechanical and battery operated pumps are available.

The first principle of the WHO cancer pain treatment
guideline reflects a fundamental principle of good medical practice: the least
invasive medical intervention that is effective should be used when treating
patients. As injectable analgesics provide no benefit over oral pain
medications for most patients with chronic cancer pain, the WHO recommends the
use of oral medications. Also, using oral medications eliminates the risk of
infection that is inherent in injections and is particularly elevated in patients
who are immuno-compromised due, for example, to HIV/AIDS, chemotherapy, or
certain hematologic malignancies. When patients cannot take oral medications
and injectable pain relievers are used, it recommends subcutaneous
administration (under the skin) to avoid unnecessary repeated sticking of
patients.[86] Hence,
oral morphine, which the WHO considers an essential medicine that must be
available to all who need it, is the cornerstone of the treatment guideline.[87]

In Ukraine, however, oral morphine is not available at all.
In fact, it is not even a registered medication. A recent survey of European
countries found that Armenia, Azerbaijan, and Ukraine are the only countries in
Europe where oral morphine is altogether unavailable. Armenia is currently
looking for a supplier of oral morphine.[88] The
only non-injectable strong opiod analgesics available in Ukraine are Fentanyl
patches that release the analgesic through the skin but at a cost of about 267
to 467 hryvna (US$33.75 to 58.38) per patch (active for three days). They are unaffordable
for most Ukrainians and are not available in government clinics and most
pharmacies.[89]

While the WHO recommends that injectable pain relievers
should be injected under the skin, standard practice in Ukraine is to give
morphine by intramuscular injection. This means that patients who get morphine
every four hours, as recommended, are unnecessarily injected six times per day.
On average, patients with advanced cancer who have severe pain require 90 days
of treatment with morphine, so a typical patient receiving morphine every four
hours would get injected in the muscles 540 times over that period. In
interviews, patients and their families said that receiving multiple injections
in the muscles was unpleasant, but they were also resigned to the fact that the
alternative—unrelieved cancer pain—was far worse.

Patients who are emaciated due to their illness face
particular difficulties with intramuscular injections as they have little
muscle tissue left. In such patients it may be challenging to vary the place of
injection and there is a risk that part of the morphine will end up outside the
muscle tissue, resulting in poor absorption of the medication and inadequate
pain control. In interviews, both healthcare workers and patients spoke of
these difficulties. Lyubov’s daughter, for example, told Human Rights
Watch:

The last two weeks we didn’t inject in the behind
anymore. The morphine was no longer absorbed. So we started doing intravenous
injections in the hand but that’s painful … Of course, if you
compare the pain from the injection to the cancer pain it’s not
comparable…[90]

Vlad’s mother, Nadya, said that multiple injections of
morphine and other medications over the course of several years had turned her
son’s behind into a “mine field.” “There was nowhere to
inject anymore. It no longer absorbed the medication. The last months we
injected in the legs, from the thigh to the knee and in the hand,” she
said. One of the injection sites became infected and developed a small hole in
the hand. “We only just cured it when he died.”[91]
Svitlana Bulanova said that toward the end of her niece Irina’s life,
they “had no place left to inject.”[92]

Healthcare workers acknowledged occasional problems due to
emaciation. Some said that they alternated the place of injection in such
cases. For example, a nurse in district 4 said that they would do one injection
“in the shoulder, another in the hip. We switch around.”[93]
Several others said that they would switch to subcutaneous injections in such
situations.[94] Most
healthcare workers we interviewed said that they wished they had oral morphine
tablets, saying it would significantly simplify their work. The oncologist in
district 5 said: “Patients often ask for strong pain medications in
tablets but we [don’t have them].”[95]

Principle 2: “By the Clock”

Analgesics should be given “by the clock,” i.e.
at fixed [four hour] intervals of time. The dose should be titrated against the
patient’s pain, i.e. gradually increased until the patient is
comfortable. The next dose should be given before the effect of the previous
one has fully worn off. In this way it is possible to relieve pain
continuously.

Some patients need to take “rescue” doses for
incident (intermittent) and breakthrough pain. Such doses, which should be
50-100% of the regular four-hourly dose, are in addition to the regular
schedule.

The second principle reflects the fact that the analgesic
effect of morphine lasts four to six hours. Thus patients need to receive doses
of morphine at four-hour intervals to ensure continuous pain control.

This principle is not followed in rural areas because of the
requirement in Ukraine’s drug regulations that a healthcare provider
administers the morphine to the patient.[97] Our
research also found the same to be true in urban areas. Even in places where
population density is much greater and distances smaller, Ukraine’s
healthcare system does not have the capacity—or is unwilling to dedicate
the resources—to visit patients at home every four hours. So most
patients get just one or two doses of morphine, leaving them without adequate
pain control for sixteen to twenty hours every day. Even the
“lucky” patients who get three or four doses of strong pain relievers
daily face significant intervals between injections when their pain is not
properly controlled.[98]

Table 5 shows the frequency with which morphine injections
are provided to out-patients through a number of hospitals that we and our
partners visited.

TABLE 5

Hospital

Maximum frequency

Delivery System

Therapeutic
department of a Kharkiv polyclinic

Nor
more than two injections per day.

A
team of nurses and drivers delivers pain medications to patients.

Rivne
polyclinic

Generally
two injections, morning and evening. Maximum is four.

A
team of nurses and drivers delivers the injections to patients.

District
1

Generally
one injection, rarely two.

Ambulance
delivers injection in evening. If second injection is prescribed, nurse has
to administer.

District
2

One
or two.

Ambulance
delivers injection in evening. If second injection is prescribed, nurse has
to administer.

District
3

Up
to three.

Ambulance
delivers throughout district.

District
4

Three
to five.

Ampoules
are given to patients or relatives for self-administration.

District
5

One
or two (up to six if nurse offers take-home supply).

Nurses
visit; occasionally, a take-home supply is provided.

District
6

One
or two.

A
team of nurses and drivers delivers injection to patients at home but only in
the district town.

While the requirement that healthcare workers administer
every dose of morphine to the patient poses the greatest barrier to following
the WHO recommendation that morphine be administered every four hours,
insufficient training of healthcare providers is another significant obstacle.

Our interviews with healthcare workers suggest that most are
unaware of the WHO’s recommendation for four-hourly administration of
morphine. Standard procedure appeared to be to start patients on a single shot
of morphine in the evening and then add a second injection and more if patients
complain of persistent pain. None of the healthcare workers interviewed felt
that this was inappropriate or substandard medical practice. For example, the
nurse at a polyclinic in Rivne told us:

Patients generally get two ampoules
per day: in the morning and evening. It usually begins with an evening dose at
9 or 10 p.m. Sometimes it happens that the next day, the patient already asks
for more because it was enough for the night but [not for] the whole day
… Before 10 p.m. severe pain syndrome begins again. Then a new
prescription is prepared for an extra dose.[99]

A man whose mother died of cancer in 2008, explained how
doctors prescribed morphine:

They registered us. Then
the panel of doctors met [to discuss my mother’s case] and a decision was
made to prescribe morphine. At first… one injection per day. Then, if
after a week it isn’t enough in the opinion of the panel, the dose is
increased. So there is a correction of the dose over time. So we eventually got
two milliliters per day, one milliliter in the morning, one in the evening.[100]

Bridging the Intervals between Morphine Injections

The Case of Tamara Dotsenko: The
Difference Regular Administration Can Make

Tamara Dotsenko, a 61--year-old breast cancer patient,
developed severe pain in her spine and back when her cancer metastasized to
the spinal cord. In her home village, the health clinic managed her pain by
giving her an injection in the evening.

Tamara told Human Rights Watch: “In the evening
they would give me a shot. I would sleep well and didn’t feel pain. But
then during the day it was a different story: pain, pain, pain and pain
… I wanted to cry the whole time …”

The pain medications they gave her during the day wore
off too quickly to provide much relief.

When Tamara could no longer take care of herself, she
was referred to the hospice in Kharkiv. There, she got pain medications
regularly.

She said:

“Here I get totally different pain treatment.
Every six hours they give me an injection. It does not fully control my pain
but it is much better than what I had at home. It’s better than having
to bear that pain.”

Healthcare workers and patients told Human Rights Watch that
they use a large array of medications, including basic pain medications, weak
opioids, muscle relaxants and sedatives, to try to dull the pain in the
intervals between morphine doses. For example, a nurse at a polyclinic in
Kharkiv told Human Rights Watch: “We never visit patients more than twice
a day [to administer morphine]. But a regular nurse will visit to do other
injections, other analgesics or muscle relaxants.”[101]
She added, erroneously: “After all, morphine … injecting it three
times per day is not really all that recommended.” The oncologist in
district 3 said that if the three injections of morphine that the ambulance
service can deliver each day are insufficient, “we use cocktails: dimedrol
with analgin [an antihistamine with a weak pain medication], baralkhin [a weak
pain medication], sibazon [diazepam, a sedative].”[102]

While the WHO treatment guideline provides for the use of
weak pain medications and other adjuvant medications in addition to a strong
opioid analgesic to enhance its analgesic effect or treat specific problems,
they are not recommended to be used as an alternative as they are incapable of
providing adequate relief.[103]
Medications like antihistamines and tranquillizers may be appropriate to treat
specific health conditions, such as allergies, nausea, or anxiety, but in
Ukraine they appear to be used often primarily to make patients drowsy and dull
the pain. Such use is not consistent with the WHO treatment guideline.

Principle 3: “By
the Ladder”

The first step is a non-opioid. If this does not relieve
the pain, an opioid for mild to moderate pain should be added. When an opioid
for mild to moderate pain in combination with non-opioids fails to relieve the
pain, an opioid for moderate to severe pain should be substituted. Only one
drug of each of the groups should be used at the same time. Adjuvant drugs
should be given for specific indications…

If a drug ceases to be effective, do not switch to an
alternative drug of the same efficacy but prescribe a drug that is definitely
stronger.

According to the WHO
guideline, the intensity of the pain should determine what type of pain
medications a patient receives.

For mild pain, patients
should receive over-the-counter medications like Ibuprofen or Paracetamol; for
mild to moderate pain weak opioid, like codeine; and for moderate to severe
pain a strong opioid, like morphine. If over-the-counter pain medications or
weak opioids are ineffective, a stronger type of pain medications should be
provided. In the words of the guideline, “the use of morphine should be
dictated by the intensity of pain, not by life expectancy.”[105]

Leading pain experts have
estimated that about 80 percent of terminal cancer patients will require
morphine for an average period of ninety days before death.[106] But data we collected from several districts in
Ukraine, including districts where hospitals have narcotics licenses, suggest
that far fewer than 80 percent of terminal cancer patients get morphine and
that those that do generally receive it for far less than 90 days. This
suggests that many patients in Ukraine who face moderate to severe pain are
started late on morphine or do not receive the medication at all even when it
is available. The data is shown in Table 6.

Interviews with healthcare workers support this conclusion.
For example, a doctor at a specialized cancer hospital said:

We try to use morphine
very rarely because, as all narcotics, it suppresses the breathing center. For
cancer patients that is not desirable so it is a last resort. No more than
15-20% of [terminal cancer] patients get it. Generally, we try to make do with
non-opioid analgesics or with synthetics…[107]

The doctor’s reluctance to use morphine is based on a
misconception about the medication’s effects on the breathing center.
According to the WHO:

pain is the physiological antagonist to the central
depressant effects of opioids. Clinically important respiratory depression is
rare in cancer patients because the dose of the opioid is balanced by the
underlying pain.[108]

Pain does not just affect terminal cancer patients: a 2007 review
of pain studies in cancer patients found that more than 50 percent of all cancer
patients experience pain symptoms.[112]
Testimony from healthcare workers suggests that doctors rarely prescribe
morphine to patients who are still receiving curative treatment. A doctor at a
polyclinic in Kharkiv, for example, told Human Rights Watch that “the
prescribing of a narcotic drug is usually reserved for terminal
patients.”[113] The
doctor from Rivne said that “pain [in patients still receiving curative
treatment] is mostly treated with curative interventions, with chemotherapy or
radiation.”

A doctor at an inpatient medical oncology unit at the same
hospital told Human Rights Watch that she believes that patients who need
strong opioids “are not in my patient profile. We are not a hospice.
Symptomatic treatment happens at home [after release from the hospital].”[114]
Although she acknowledged that she frequently encounters severe pain in her
patients, particularly those with bone metastases, she rarely prescribes
morphine. She told Human Rights Watch: “We give non-opoid medications
like kitonol or dexalgin [weak pain medications]. If people have a clear pain
syndrome, we give tramadol. We try to avoid narcotics.” The doctor
estimated that only one patient in the past six months had been prescribed
morphine or an opioid of similar strength.

The reluctance of doctors to prescribe strong opioids to
patients who are still receiving curative treatment appears to be related to
fears that patients will become drug dependent. However, these fears are
unfounded, and the WHO treatment guideline states that “wide clinical
experience has shown that psychological dependence [drug dependence] does not
occur in cancer patients as a result of receiving opioids for relief of pain.”[115]

Development of physical dependence and tolerance to morphine
does occur but, according to the treatment guideline, are “normal
pharmacological responses” and “do not prevent the effective use of
these drugs.” If curative treatment successfully addresses the source of
the pain, the use of opioids can be tapered and, eventually, stopped.[116]

Principle 4: “For the Individual”

There are no standard
doses for opioid drugs. The “right” dose is the dose that relieves
the patient’s pain. The range for oral morphine, for example, is from as
little as 5 mg to more than 1000 mg every four hours. Drugs used for mild to
moderate pain have a dose limit in practice because of formulation (e.g.
combined with ASA or paracetamol, which are toxic at high doses) or because a
disproportionate increase in adverse effects at higher doses (e.g. codeine).

Pain is an individual experience. Different people perceive
pain differently; they metabolize pain medications in different ways; and
cancers vary from person to person, leading to vastly divergent types and
intensities of pain. With so many variables, only an individualized approach to
pain treatment can ensure the best relief to all. The WHO therefore recommends
that doctors “select the most appropriate drug and administer it in the
dose that best suits the individual.”[118]

However, our research suggests that this recommendation is
routinely ignored in Ukraine. Many doctors start patients on a standardized
dose of morphine—one that, paradoxically, is unnecessarily high for
many—and some arbitrarily cap the daily dose of injectable morphine at a
maximum of 50 mg, as wrongly recommended by the Ministry of Health and the manufacturer,
even if that is inadequate to control the patient’s pain. Both constitute
poor medical practice that leads to unnecessary patient suffering.

Standardized Starting Dose

Finding the right dose of morphine for the individual
patient is crucially important: if the dose is too low, the patient's pain will
be poorly controlled, if too high, the patient will experience unnecessarily
severe side effects, including drowsiness, constipation, and nausea. With the
right dose, relief is maximized, side effects are minimized, and any drowsiness
or confusion should clear up within three to five days.

However, our research suggests that it is common practice in
Ukraine for doctors not to determine the appropriate dose on an individual
basis. Instead, they prescribe one ampoule of morphine, which contains 8.6 mg
of injectable morphine, equivalent to 25.6 mg of oral morphine.[119]
This means that some patients receive too much morphine and face needlessly
debilitating side effects, while others receive doses that are too small to
give full relief.

Viktor Bezrodny, a man whose mother died of gallbladder
cancer, told Human Rights Watch that doctors never tried to establish the right
dose of morphine for his mother but just prescribed the standard dose of one
ampoule. But the morphine injections made her drowsy. He said:

She would sometimes refuse the injection because she
didn’t want that state of cloudiness. She kept it [morphine injection] as
a last resort. She would say: ‘Let’s take these drops … everything
hurts but let’s do the injection later.’[120]

Bezrodny, himself a doctor, told us he doubted any doctor
would prescribe part of an ampoule: “If I prescribe a half ampoule I have
to somehow account for the rest…”[121]

Roman Baranovskiy, whose mother-in-law died of metastatic
lung cancer in 2009, told us that he divided the ampoules himself and injected
them in installments. His mother-in-law’s hospital allowed patients to
take home a three-day supply of morphine and administer it themselves. He said:

I did not inject two ampoules right away [as
prescribed]. I divided them. If you give a large dose, the person falls
asleep … [People with pain] when they get relief will relax anyway and
become sleepy. But when the person fades and can’t open their eyes,
that’s unnecessary. Even one ampoule was sometimes too much.[122]

Most doctors interviewed said they never prescribe partial
ampoules but contended that the practice of first prescribing omnopon or
promedol, opioid analgesics that are less potent than morphine,
constituted a form of titration. A cancer doctor in Rivne, for example, said
that he does not prescribe half ampoules because of the need to account for the
other half. But he said that he usually starts by prescribing omnopon
and promedol and only prescribes morphine when these are no longer
effective.[123]

Maximum Daily Dose

While the WHO treatment guideline specifies that the
‘right’ dose is one that “relieves the patient’s pain”
and that some patients may need “more than 1000 mg [of oral morphine]
every four hours,” the Ukrainian manufacturer of morphine and
Ukraine’s Ministry of Health both recommend a maximum daily dose of 50 mg
of injectable morphine, equivalent to 150 mg of oral morphine.[124]

The maximum daily dose recommendation is particularly
problematic because it is very low. Since most patients require 10-30 mg of
oral morphine every four hours, or 60 to 180 mg per day, even patients who fall
on the high end of this typical range in Ukraine exceed the maximum dose
recommendation if they get their medications every four hours.[125]
Doctors at hospices in Kharkiv and Ivano-Frankiivsk, which observe WHO’s
recommendations, estimated that about 10 percent of their patients require more
than the maximum dose recommended.[126] A 2010
Human Rights Watch survey of barriers to palliative care found that Ukraine and
Turkey were the only two of ten European countries surveyed to impose a maximum
daily dose for morphine.[127]

Asked whether they followed the recommendation,
doctors’ responses varied greatly. Some said that they did not, while
other insisted that they had to. One doctor, for example, told Human Rights
Watch that his polyclinic ignores the maximum dose recommendation, citing what
he called a “basic principle in medicine” that “no matter
what the health condition is, patients should not suffer.”[128]
Another oncologist said: “It’s possible [to prescribe more] when
patients need it. The main thing is to professionally justify the prescription
in the patient’s file so as to avoid problems with inspections.”[129]
He recalled a patient who had been on 12 ampoules (103.2 mg) of morphine daily
for a five-year period.[130] But
the oncologist in district 3 said that his clinic cannot prescribe more than what
is recommended, even though some of his patients, primarily those with
metastases in the bones, cannot achieve good pain control within the
recommended daily dose. He said:

Often these patients are in the hospital. There, they
receive narcotics three or four times [per day] and [healthcare workers]
constantly provide additional analgesics: weak, strong analgesics. They mix.
But we never prescribe more than recommended.[131]

The oncologist also expressed the erroneous opinion that
giving more than the recommended daily dose would be ineffective and negatively
impact the patient’s breathing and organs.[132]
As Lyubov’s case demonstrates, where doctors do strictly follow the
recommendation, the result can be great suffering.

But our research found that some doctors are even reluctant
to prescribe 50 mg of injectable morphine daily. Vlad’s mother had great
difficulty getting doctors to prescribe her son more than three ampoules of
morphine, even though he continued to have excruciating pain. She described the
battles she had to fight:

I demanded a fourth ampoule because he was in bad shape. A
panel of doctors came to our house. The chief doctor … took off his
underpants, lifted up his clothes, and checked whether he was abusing drugs.
Then she accused me of selling drugs.[133]

Rather than recognize the morphine was insufficient for
controlling his pain, doctors first accused Vlad of being a drug addict, then
his mother of selling drugs. She told Human Rights Watch that she finally went
to the city health department and a member of the local parliament to receive
permission to switch to a different hospital.

Eventually, doctors prescribed Vlad a fourth ampoule, but
even that was insufficient to control his pain and his mother had to again
fight doctors to prescribe a fifth:

I went to the chief doctor [of the hospital], the chief
medical officer. [There was] again a scandal. The doctors said: ‘A fifth
ampoule is an overdose [is too much]. Michael Jackson died of an overdose. Now
they’re prosecuting an innocent doctor. And no one is supporting that
doctor. It’ll be like with Michael Jackson.’ And I said: ‘But
he screams from the pain, disturbs the neighbors; you don’t know how he
howls, how much pain he has. People [neighbors] hear how he howls in the
apartment. I can’t be in the apartment. I will go crazy the way he
howls.’[134]

Finally, the hospital sent a group of doctors to their
apartment to determine whether a fifth ampoule was really needed. Vlad’s
mother said:

After the visit, there
was silence…. I waited and waited and they did not bring the fifth
ampoule. I went to the neurologist and said: ‘You’ve seen him.
Can’t you talk to the chief doctor?’ He did and they finally gave
us the fifth ampoule.[135]

Principle 5: “Attention to Detail”

Emphasize the need for regular administration of pain
relief drugs. Oral morphine should be administered every four hours. The
first and last dose should be linked to the patient’s waking time and
bedtime. The best additional times during the day are generally 10:00, 14:00
and 18:00. With this schedule, there is a balance between duration of analgesic
effect and severity of side effects.

To ensure quality of life for patients with pain, it is not
just important to get pain medications regularly but to get them at times that
fit their schedule. In order to maximize sleep at night, for example, patients
should take their medications shortly before bed time.

However, several healthcare workers and patients told us
that the last injection of morphine would typically be scheduled for 6 to 8
p.m. to accommodate nurses’ shifts. As morphine acts for just four hours,
that means that the effects will have worn off for these patients before
midnight, setting them—and their relatives—up for a restless night.
When Vlad was receiving three ampoules of morphine per day, for example,
healthcare workers determined that he would receive his injections at 9 a.m., 2
p.m., and 6 p.m. His mother said:

He often didn’t sleep at night. He’d be in
agony because of the pain. Then he would sleep long in the morning. So they
would arrive at 9 a.m. and he would be asleep. I would say: ‘Leave the
medication. I’ll take the syringe. When he wakes up, that’s when
it’s important for us to give him the injection. He’s still
sleeping.’ [But they would wake him up and] he would say: ‘Nothing
hurts right now. I’m sleeping. I don’t need it.’ But they,
like zombies, would insist: ‘No, it’s necessary. We will not come
another time. Your prescribed time is 9 a.m. So they would inject him while he
was sleeping because they had to do the injection and leave.

The chief doctor in district 3 acknowledged the importance
of providing pain medications when the patients need it most. He said that his
hospital tried to accommodate patients as much as possible:

At the request of relatives, we can do injections until 10
p.m. but not later … In the terminal stages the medication is not
sufficient if you give injections at 6 a.m., noon and 6 p.m. By midnight, he
will be screaming.[137]

But he noted that in places where regular nurses and drivers
employed by clinics, as opposed to the ambulance service, are responsible for
delivering pain medications, it becomes difficult to deliver them that late:

The driver works a
specific shift. [What happens] if morphine is prescribed for 6 p.m. and the
driver’s shift is over at 2:30 p.m. Why does he have to work after hours?
Or someone needs to pay him extra. But with our budget deficits…[138]

Some doctors and nurses told us they tried to accommodate
their patients by leaving ampoules or filled syringes with them or their
relatives, even though this violates Ukraine’s drug regulations. In such
cases, patients can choose themselves the best time to take the medication. For
example, Viktor Bezrodny told Human Rights Watch:

The nurse would come. In principle, she was supposed to do
the injection but she came at a time that was good for her but when, for
example, my mother might sleep. [She allowed me] to load the morphine into the
syringe and give her the injection when she actually needed it.[139]

Problems with Treatment of Non-Cancer Pain

While pain treatment for cancer patients in Ukraine is
severely inadequate, it is even worse for other types of patients due to a lack
of recognition amongst healthcare workers that severe pain is common in people
who suffer other health conditions and should be treated.

Our research found that doctors are often unwilling to treat
such pain, preferring to treat its cause. Under international human rights law,
all patients facing severe pain have an equal right to pain treatment,
irrespective of the type of underlying illness or condition.[140]
The story of Oleg illustrates the problems that many of these patients face.

The Story of Oleg Malinovsky

Oleg
Malinovsky with his dog before he became ill. Courtesy of Malinovsky family.

Oleg, a 35-year-old man from Kiev, has been
diagnosed with chronic hepatitis C and a range of other illnesses. Oleg’s
acute medical problems started in early 2008, shortly after he began treatment
for a hepatitis C infection. When he developed numbness in several fingers,
doctors hospitalized him for tests and treatment. At the hospital, he
contracted a staphylococcus infection, developed recurring high fevers and
experienced increasingly severe pain in his hip joints. The treatment he
received was not effective. On the contrary, his problems rapidly worsened.

A degenerative process
had started in his joints. Oleg’s pain then spread to his lower spinal
area before rapidly worsening in July 2008, several weeks after doctors started
rheumatology treatment. As any movement of his hips and knee joints caused
severe pain, Oleg was forced to lie completely still in his bed throughout the
day. His wife told us:

The pain was intolerable with any movement and became more
severe with every day because of the pathological process in his hip
joints. The pain affected his sleep, appetite, and his psychological
condition. He became very irritable and nothing could make him happy anymore. A
normal sneeze or cough caused him terrible pain … You could knock on the
wall, and if he was lying over there, he would scream [in pain]...[141]

At the Kiev City Rheumatology Center, where he was being
treated, doctors eventually agreed to give Oleg a small daily dose of morphine
to allow him to sleep at night. But he still faced undiminished pain at other times
of the day.

In March 2009 doctors surgically removed portions of the
bone in his stiffened joints, resulting in a reduction of pain and some
restored mobility. But in September 2009 Oleg again developed persistent and
severe pain, this time involving his wrists and elbows. Again, he had to keep
completely still in bed. He was unable to move his limbs, preventing him from
any activity whatsoever, including eating, washing, or reading. Oleg routinely
screamed in pain. Sometimes, the neighbors would knock on the walls because he
disturbed them. Oleg repeatedly told his wife that he wanted to die because he
could no longer bear the pain.

Over the next seven months Oleg and his wife repeatedly told
doctors at their public hospital about the pain he was suffering and asked them
to prescribe appropriate pain medications. But instead of prescribing morphine,
which had been effective before, his doctors procrastinated. They sent Oleg to
a psychiatrist to assess whether his depression and irritability were related
to an underlying psychiatric condition, and they sent him to drug treatment
doctors because they thought he was addicted to morphine, even though he had
not had any in more than six months.

When the psychiatrist and drug treatment doctor confirmed
that Oleg suffered from symptom-related depression rather than a mental
disorder and ruled out drug dependence, the chief of the clinic promised to
prescribe stronger pain medications. Nothing happened.

Eventually, in March 2010, Oleg’s pain improved
somewhat on its own. He never got strong pain medications, continues to be
bedridden, and experiences significant pain when he moves. Oleg and his wife
have filed complaints with the prosecutor’s office and courts in Ukraine
about the denial of appropriate pain treatment. So far, the courts have refused
to consider the complaints and the prosecutor’s office has not opened an
investigation.

Treating Pain in Patients with a History of Illicit Drug
Use

Patients with severe pain who use illicit drugs or
have in the past pose a challenge to healthcare providers. These patients
have a right to pain management, including with strong opioid analgesics
where clinically appropriate, just as any other patient does. But physicians
need to pay special attention to ensure that the pain treatment these
patients receive is effective and to minimize the risk of misuse of
medications.

At present, there are no international guidelines for
treating pain in people with a history of illicit drug use, but there is
significant clinical experience. Dr Steven Passik of Memorial Sloan Kettering
Cancer Center in New York, USA, is a leading expert on treating pain in
people with a history of illicit drug use. He recommends that physicians
conduct an individual risk assessment, such as the Opioid Risk Tool or SOAPP
(Screener and Opioid Assessment for Patients in Pain), to assess the risks of
starting a patient who may have a history of illicit drug use on strong
opioid analgesics. Based on the risk assessment, the physician should develop
a treatment plan that ensures good pain treatment and minimizes the risk of
relapse or misuse. He recommends the following precautions for patients with
a history of illicit drug use:

Put such patients on long
acting opioids, such as methadone, slow-release morphine, or fentanyl
patches.

Physicians
should carefully assess and monitor the patient’s dosage requirement.
People with a history of illicit drug use often have a significantly higher
tolerance for opioid medications or build up such tolerance more rapidly and
may thus require higher dosages to achieve adequate pain control. Patients
who receive doses that are too low are more likely to develop drug seeking
behavior and start self-medicating, which can easily slide into renewed
illicit drug use.

Physicians should
limit the number of pills the patient has in his or her possession at any
given time. Dr Passik said: “Giving someone with a history of illicit
drug use an unmanageably large supply of short-acting opioid pills is asking
for trouble.”

Physicians should
see such patients frequently to monitor the efficacy of and adherence to the
pain treatment as well as to assess possible illicit drug use. Potential
problems should be identified at an early stage and addressed in a timely
manner.

Physicians
should help get the patients who are active drug users into a treatment
program, including maintenance treatment and/or a twelve-step program.

Physicians
must avoid being perceived to be judgmental when it comes to illicit drug
use. The patient-physician relationship is a key factor in keeping a patient
with a history of illicit drug use from misusing pain medications.

Basu et al.
describe a similar approach to treating pain in people living with HIV who
have a history of substance abuse in “Pharmacological pain control for
human immunodeficiency virus-infected adults with a history of drug
dependence,” Journal of
Substance Abuse Treatment, vol. 32 2007), pp. 399-409.

Broader Palliative Care Services

The insecurity is so difficult. I don’t know
what’s coming. Sometimes I think I should ask someone for something and
take it and die. Sleeping is good. You forget your thoughts. Better sleep
than have all sorts of ideas.

—Tamara
Dotsenko

While physical pain is often the most immediate
symptom that patients with advanced cancer and other life-limiting illnesses
face, many patients also experience tremendous emotional, psychological, and
spiritual pain. With a number of basic and inexpensive interventions, palliative
care can often provide considerable relief of these symptoms.

In Ukraine, some psychosocial and spiritual services
exist in hospices and hospitals with palliative care beds, but they are
altogether lacking for most patients at home. The public healthcare system
focuses only on the physical condition of patients. A few lucky patients
receive such support from NGOs that offer home-based palliative care services.
The vast majority does not.

The lack of psychosocial care for patients at home is
puzzling given that Ukraine’s current system of delivering pain
treatment already involves nurses visiting such patients. At present,
however, these nurses just administer morphine and leave; they do not provide
psychosocial support to patients and their families, no matter how heavy
their burden. Viktor Bezrodny, for example, told us: “The nurse would
come into the corridor. I loaded the syringe… She took the empty
ampoule and we parted. She did not go to the patient.” (Human Rights
Watch interview with Viktor Bezrodny, April 15, 2010.)

Similarly, Katerina Potapenko, the 62-year-old wife of
Arkadi, a 63-year old patient with appendix cancer, told us that the nurses would
come to her house at 9 p.m., clean the area of the injection, administer the
shot, and leave. But the full burden of care-giving falls to her, an elderly
woman who had recently suffered a heart attack herself. She told us:
“I’m both doctor and nurse. I do everything [even though] I am
sick myself.” (Human Rights Watch and Rivne Branch of All-Ukrainian
Network of People Living with HIV interview with Katerina and Arkadi
Potapenko, April 20, 2010.)

For all its inadequacies for delivering pain
treatment, Ukraine’s visiting nurses system could form the basis for
providing comprehensive home-based palliative care services. With some
training, these visiting nurses could coach families in providing high
quality home-based care, including managing of pain and other physical
symptoms and addressing the psychosocial and spiritual needs of the patient.

IV. Exploring the Causes of Untreated Pain

The World Health Organization has urged countries to adopt
national or state policies that support pain relief and palliative care; enact
educational programs for the public, healthcare personnel, regulators, and
other relevant parties; and modify laws and regulations to improve the
availability and accessibility of drugs, especially opioid analgesics.[142]
It has noted that such measures, fundamental for the development of palliative
care, “cost very little but can have a significant effect.”[143]

The WHO’s recommendations correspond closely with
several core obligations, which countries must meet regardless of resource
availability, under the right to health. The Committee on Economic, Social and
Cultural Rights (CESCR), which monitors implementation of the right to health
as articulated in the International Covenant on Economic, Social and Cultural
Rights (ICESCR),[144] has
held that countries must adopt and implement a national public health strategy
and plan of action and ensure access to essential drugs as defined by the WHO.[145]
It has identified providing appropriate training for health personnel as an
obligation “of comparable priority.”[146]

The Ukrainian government’s failure to take sufficient
steps in these three areas not only violates the right to health, it is the
primary reason for problems with palliative care and pain treatment identified
in previous chapters. While the government has created a significant number of
palliative care beds in public hospices and hospitals, as well as an Institute
of Palliative and Hospice Medicine in the Ministry of Health, it has not taken
adequate steps to ensure availability of essential palliative care medicines
like oral morphine, develop a system of home-based palliative care, improve
instruction for healthcare workers, or address major drug regulatory problems.

Policy

To successfully address the problems described above, a
concerted and coordinated effort by a broad range of governmental and other stakeholders
is needed: oral morphine must be introduced, a home-based palliative care model
developed, instruction for health workers revamped, and drug regulations
reformed.

As a party to the International Covenant on Economic, Social
and Cultural Rights, the government has the responsibility to ensure that
people with life-limiting illnesses can enjoy their right to health. It thus
has to take the lead in addressing the barriers that currently impede the
availability of good palliative care and pain treatment.

The Ukrainian government needs to play a much more proactive
role, although it has started to take some policy steps in this direction. In
2008 it established an Institute of Palliative and Hospice Medicine within the
Ministry of Health and named Professor Yuri Gubsky as its head. The
institute’s mandate includes developing state programs and control over
their implementation; coordinating efforts to establish a network of health
institutions that provide palliative care; providing organizational and
methodological support to such institutions; and conducting research.[147]
Tasked with developing the government’s approach to palliative care, the
institute has developed a draft national palliative care concept program that
was submitted to the cabinet of ministers in October 2008.[148]
The draft concept was sent back to the Ministry of Health a month later for
technical reasons. To date, a new draft concept program has not yet been
submitted to the cabinet of ministers, leaving Ukraine without a clear plan for
developing palliative care.

As a result,
Ukraine’s efforts to develop palliative care have lacked cohesion,
urgency, and coordination. While the government has taken a number of important
steps to enhance palliative care provision in healthcare institutions, it has
not done so to ensure oral morphine becomes available, or to promote home-based
palliative care. While the Institute of Palliative and Hospice Medicine has
started continuing medical education courses on palliative care, there have
been no centralized efforts to incorporate adequate palliative care instruction
into medical school curricula or to develop a palliative care treatment
guideline. While Ukraine’s drug regulators have made some changes to drug
regulations to improve the availability of controlled medications, they have
not addressed some of the most problematic provisions.

Education of Healthcare Workers

Lack of knowledge among healthcare workers about palliative
and pain treatment services is one of the biggest obstacles to palliative care
in many countries around the world. A dearth of training on the topic means
that many healthcare workers do not fully understand palliative care or have
the skills to provide it and subscribe to a variety of myths and misconceptions
about strong opioid analgesics.

Most healthcare workers interviewed were unaware or only
partially aware of international best practices for pain treatment. Many
doctors and nurses expressed the erroneous belief that giving patients morphine
would turn them into “drug addicts”; confused physical dependence
and tolerance with dependence syndrome (addiction); interpreted patient
requests for more morphine as a sign of “addiction” rather than as
a sign that the current dose was insufficient; believed that one dose of
morphine could provide relief far beyond the four to six hours it is active;
and that a maximum daily dose was appropriate.

Healthcare workers’ inadequate knowledge about
palliative care and pain treatment appears to be a direct consequence of the
failure of Ukraine’s medical schools, which are all public institutions,
to provide sufficient instruction on pain management and palliative care for
medical students. According to palliative care experts, few medical
universities have introduced specific instruction on palliative care. The
mandatory undergraduate curriculum in medical schools does not include any
specific instruction on palliative care, and classes about pain treatment focus
primarily on acute pain (post-surgical pain, for example) rather than chronic
or cancer pain.[149] While
the WHO pain relief ladder is briefly mentioned, it is not studied in any
detail or used in practice. In pharmacology, students learn about the
pharmacological characteristics of morphine rather than its use in clinical
practice.

After medical school, graduates in Ukraine go through a
two-year initial specialization phase and enroll into residency programs
depending on their specialization. At present, only 2 of about 19 teaching institutions
offer palliative care services so most doctors specializing in oncology or
anesthesiology receive no practical exposure to palliative care and pain
management. Even doctors specializing in oncology do not currently do rotations
in hospices. As a result, the next generation of Ukrainian doctors is educated
with very limited exposure to palliative care services.

At present, just two medical institutions in Ukraine offer
continuing medical education courses in palliative care: the Shchupik National
Medical Academy for Post-Graduate Education and the post-graduation faculty of
the Ivano-Frankiivsk Medical University. Two departments of the National
Academy offer such courses. In 2010 the department of palliative care of the National
Academy started offering one and two-week courses on palliative care throughout
the year for oncologists, general practitioners, and nurses. The courses
include bedside training.[150] The
department of gerontology has organized palliative care courses since December
2009. The Ivano-Frankiivsk Medical University has included forty hours of
palliative care training, including clinical training in the local hospice and
in its continuing medical education courses for general practitioners.[151]
All general practitioners must complete post graduate education courses once
every five years.

Our research also found a conspicuous absence of
evidence-based resource materials on palliative care in Ukrainian. Apart from a
treatment guideline on HIV and palliative care, the Ministry of Health and
professional associations have not developed clinical guidelines for palliative
care or pain treatment in patients with cancer and other conditions. Textbooks
used in medical and nursing schools contains little information about
palliative care.[152]
Pharmacology textbooks used in Ukrainian medical schools are based on a
Soviet-era book that contains inaccurate information about morphine dosing.[153]

All Ukraine’s medical schools are public institutions
that operate under the auspices of the Ministry of Health. The government is
thus clearly in a position to ensure that adequate instruction on palliative
care is provided. Human Rights Watch believes that all medical students should
receive basic instruction on palliative care and pain treatment. Those whose
specialize in disciplines that frequently care for people with life-limiting
illnesses should receive detailed instruction and exposure to clinical
practice. Failure to do so will result in a violation of the right to health.

Drug Availability

Ukraine’s drug regulations are at the heart of several
of the problems with palliative care and pain management identified in previous
chapters. Very strict licensing requirements have made morphine unavailable in
many rural areas, and the requirement that healthcare workers must directly
administer morphine to patients has led to antiquated, non-evidence based pain
treatment practices. But Ukraine’s drug regulations also create a
significant administrative burden for healthcare workers who prescribe opioid
medications and impose a very strict control regime that generates a sense of
trepidation about prescribing opioid medications among many healthcare workers.
These two factors likely contribute to the reluctance among many healthcare
workers to prescribe these medications and an unwarranted delay in the onset of
treatment for severe pain.

Under the 1961 Single Convention on Narcotic Drugs,
governments must regulate the manufacture, distribution, and prescription of
controlled substances to prevent their misuse. But the convention also
recognizes that these substances are “indispensable for the relief of pain
and suffering” and that states must make “adequate provision to
ensure [their] availability … for such purposes.”[154]
In the words of the International Narcotics Control Board, the body that
monitors implementation of the UN drug conventions, the 1961 convention:

… establishes a dual drug control obligation: to
ensure adequate availability of narcotic drugs, including opiates, for medical
and scientific purposes, while at the same time preventing illicit production
of, trafficking in and use of such drugs.[155]

The 1961 Single Convention on Narcotic Drugs lays out three
minimum criteria that countries must observe when developing national
regulations on handling controlled medications:

Individuals must be authorized to dispense opioids by their
professional license to practice or be specially licensed to do so.

Movement of opioids may occur only between institutions or
individuals so authorized under national law.

A medical prescription is required before opioids may be
dispensed to a patient.

Additionally, countries also have to keep records on the use
of controlled medications.[156]

Impact of Drug Control on Medicine Availability: The Example of
Tramadol

Tramadol is a weak opioid pain medication used to
treat moderate to severe pain. In Ukraine, as in most countries, it was a
regular prescription medication widely used for pain management. Unlike
morphine, the use of which was mired in bureaucracy around prescription,
tramadol was a hassle-free pain medication that was significantly stronger
than over-the-counter pain medications. Doctors could write a simple
prescription and patients could buy the medication at any pharmacy. In fact,
most pharmacists sold tramadol without a prescription as well.

However, the easy availability of the drug had adverse
consequences. Although tramadol has unpleasant side effects, many drug users
started using it to mitigate the effects of withdrawal when they did not have
access to other drugs. Teenagers began experimenting with tramadol at
schools; for many, tramadol was their first experience with drug use.

Ukraine’s law enforcement agencies became
increasingly concerned about the way tramadol was being used for non-medical
purposes. Instead of enforcing existing rules for prescription
medications—stopping pharmacists from giving out such medications without
a prescription—the government applied an increasingly restrictive
prescription regime to the medication and, eventually, scheduled it as a
narcotic drug in June 2008.

The effect of this decision on the availability of
tramadol for legitimate medical purposes has been dramatic. According to the
pharmacological center of the Ministry of Health, four producers of tramadol
discontinued production. Many pharmacies were no longer allowed to stock the
medication because they did not have narcotics licenses. For healthcare
providers, it became as problematic to prescribe tramadol as morphine, so
many stopped doing so. One oncologist told Human Rights Watch:
“Prescribing tramadol is such a hassle that you might as well prescribe
morphine.” A chief doctor at a central district hospital said there is
not one pharmacy that stocks tramadol in his entire district of some 35
thousand people.

Government estimates for domestic production of
tramadol show a dramatic decrease from 2008 to 2010. In 2008 the government
estimated production at 19.5 and 6.5 million grams of oral and injectable
tramadol for the year. In 2010, its estimate was 1.88 million grams of
tramadol or almost 14 times less.

The convention permits governments to impose additional
requirements if deemed necessary.[157]
However, as WHO has observed that “this right must be continually
balanced against the responsibility to ensure opioid availability for medical
purposes.”[158]
In other words, regulations should not unnecessarily impede access to
controlled medications. WHO has developed guidelines that governments can use
to develop what it has called a “practical system” of regulating
healthcare workers’ handling of controlled medications, as well as
guidelines for ensuring that drug control policies are properly balanced.[159]

Ukraine’s drug regulations have a strong focus on
prevention of misuse of controlled medications, with many of their provisions
going far beyond what is required by the UN drug conventions. Human Rights
Watch recognizes that prevention of misuse is of particular importance in
countries which, like Ukraine, face major problems with illicit drug use as
well as significant corruption in the healthcare sector.[160]
However, our research shows clearly that some provisions in Ukraine’s
drug regulations are so burdensome and have such a restrictive impact on the
availability of controlled medications for legitimate medical and health
purposes that they lead to violations of the right to health.

Many of the healthcare workers we interviewed for this
report were also concerned about the negative impact of drug regulations on
legitimate medical practice. While all supported strict regulation of opioid
analgesics, many felt the current regulatory regime was excessively and
unnecessarily burdensome. They said that certain aspects of the regulations
strongly interfered with the delivery of adequate pain treatment services and
were not necessary to prevent misuse.

Ukraine’s government has begun to address some of the
problematic provisions in its drug regulations. It has created a working group
on pain treatment that is responsible for reviewing drug regulations. In 2010
Ukraine adopted a new regulation, Order 11, which somewhat relaxed the
requirement that healthcare workers directly administer strong opioid medications
by allowing self-administration of oral medications. This change means that if
Ukraine introduces oral morphine, healthcare workers will be allowed to provide
them with a take-home supply. In October 2010 in meetings with Human Rights
Watch and the International Renaissance Foundation, Volodymyr Tymoshenko, the
head of the National Drug Control Committee and Elena Koval of the department
on licit narcotics circulation of the Interior Ministry stated that they were
deeply concerned about the lack of narcotics licenses among rural pharmacies
and health clinics.[161]
Tymoshenko said that he had raised these concerns with regional officials and
encouraged them to ensure that more pharmacies obtained narcotics licenses.[162]

Licensing Requirements

Under the UN drug conventions, controlled medicines may only
be handled by individuals and institutions that are licensed to do so. This
means that healthcare institutions and workers need to be licensed before they
can stock, prescribe, or dispense opioid analgesics. Countries may set up a
special licensing procedure for healthcare institutions and workers or
permission to handle opioid medications can be part of the general license to
operate a healthcare institution or professional license. Countries that
require a separate license for institutions or healthcare workers should ensure
that licensing requirements and procedures are transparent and efficient and do
not create barriers to the availability and accessibility of these essential
medications.

In Ukraine, healthcare institutions and pharmacies must
obtain a special license from the National Drug Control Committee to be allowed
to handle controlled medicines like morphine. This license also specifies which
staff members of the institution are authorized to handle the medications. In
interviews with Human Rights Watch, health administrators generally described
the procedure for obtaining these licenses as smooth and unproblematic but said
that some of the requirements a healthcare provider or pharmacy must meet to be
able to get the license are problematic for many.[163]
Health clinics known as feldshersko-akusherski punkty are ineligible to
get a narcotics license.[164]

Ukraine’s regulations set out a number of criteria
that a healthcare institution must meet before a license can be issued
(summarized in Table 7).[165] Many
of these requirements are significantly stricter than what is required by the
UN drug conventions or is practiced in neighboring countries like Poland or
Romania but most are not unreasonable. As long as they do not have an
unjustifiably restrictive impact on the availability of controlled medicines
for healthcare purposes, they are consistent with the right to health.

TABLE 7

Requirement

Details

Documents Required

Qualified Personnel

Management of facility must include a specialist with
relevant professional training.

Personnel with access to controlled medications must have
relevant professional training. This requirement is differentiated for
different types of healthcare facilities and pharmacies, with fewer
requirements for lower level facilities.

Certified copies of qualifications of management and
personnel with access to the controlled medications.

No Counter Indications for
Personnel

Personnel with access to controlled medicines may not have
a mental disorder related to drug or alcohol abuse; may not have been
declared ineligible to handle narcotics; may not have a criminal record
related to illicit drugs and certain types of other criminal offenses.

Personnel must obtain relevant certificates from state drug
treatment clinics and police once per year.

Appropriate Material Conditions

The facilities must be such that secure and safe conditions
can be created for keeping and accounting for narcotics.

The Ministry of Interior must conduct an inspection at the
site and issue a permit certifying that the premises meet requirements.

Appropriate Sanitary Conditions

Premises must meet the requirements of Ukraine’s
sanitary norms and rules for storing of narcotics.

Conclusion from the State Sanitary-Epidemic Service.

Legal entity

The healthcare provider must be a legal entity.

But the requirements for storage premises (see Table 8) are
highly problematic.[166] Most
notably in practical terms for rural health clinics and pharmacies is the need
for an alarm system. While there is no legal requirement that the alarm system
be hooked up to the local police department, doctors at several rural hospitals
said that this was a requirement in practice, and that the recurring monthly
cost of such system, which one doctor put at 1400 hryvna (US$175), was too
great for many clinics.

TABLE 8

Requirements
for premises used for operations with narcotic drugs

Hospitals,
pharmacies

Health
clinics (ambulatoria)

Location
of storage

Must be a separate room located in a
“capital building.”

Walls

Walls must be equivalent in strength to a
cement wall of a width of no less than 500 mm

No special requirements for the walls of the
room.

Floors
and ceilings

Floors and ceilings must be equivalent in
their strength to a reinforced concrete plate no less than 180 mm wide

No special requirements for the floor/ceiling
of the room.

If above requirements
for walls, floors and ceilings are not met, the entire area of the walls,
floor, and ceiling must be reinforced from the inside with steel bars of no
less than 10 mm in diameter, and the size of openings no more than 150 x 150
mm. The bars must be welded to the walls or plates that are clear of laying
and covered by anchors with diameter a no less than 12 mm and with a step of
500 x 500 mm. Where it is impossible to install anchors, fittings made of
steel strips may be embedded with dimensions of 100 x 50 x 6 mm are attached
to reinforced concrete surfaces with four dowels.

Entrance
doors

Entrance doors must be durable, well fitted
to the door frame; metal or wooden "full-body;" no less than 40 mm
wide; must have two built-in, non-self-locking locks.

Entrance doors must be durable, well fitted
to the door frame; metal or wooden "full-body"; no less than 40 mm
wide; must have two built-in, non-self-locking locks.

Windows

Window openings must be equipped with metal
bars from inside or between frames; it is permissible to use decorative bars
or blinds with the strengths no less than that of the metal bars.

Window openings must be equipped with metal
bars from inside or between frames; it is permissible to use decorative bars
or blinds with the strengths no less than that of the metal bars.

Storage
locker

No special requirements.

The premise must be
equipped with vaults or metal boxes attached to the floor (walls).

Alarm
system

The premise must be
equipped with an alarm system that protects potential entry routs: window and
door openings, ventilation routs, heat inputs, and other elements of the
premise accessible for ingress from outside; the doors must be blocked for
opening and breaking; the windows must be protected against opening and
breaking of the window glass; non-capital walls, ceilings, places of service
lines entry must be protected against breaking; capital walls, ventilation
boxes must be protected against collapse and breaking force; the alarm signal
must be transmitted to the board of centralized monitoring of a department of
internal affairs.

The premise must be equipped with an
autonomous alarm system that protects the inside space and surfaces of the
premise, vaults (metal boxes) that are used for storage, and an alarm signal
that transmits to the board of centralized monitoring or to local sound or
light signaling devices.

Other
requirements

Premises, vaults and metal boxes:

must
be locked at the end of work with narcotic drugs;

at
the end of a working day, must be sealed and turned over to the security.

Premises, vaults, and metal boxes:

must
be locked at the end of work with narcotic drugs;

at
the end of a working day, must be sealed and turned over to the security.

These requirements are the primary reason for the limited
availability of opioid analgesics in rural clinics described in Chapter II.
Healthcare workers at all central district hospitals we visited told us how
problematic these requirements are for rural clinics and pharmacies. The chief
doctor in district 3, for example, said:

We currently pay 1400 hryvna [about US$175] per month for
[an alarm system at] one facility. [In this district, we have] 12 ambulatoria
plus the central district hospital. You can calculate [the cost if all health
clinics had narcotics licenses]…. It is just not rational.[167]

To outfit the room, the walls have to be a certain size,
these kinds of bars, such a safe that is attached [to the floor], a door that
is reinforced, and an alarm system. You know, we could build additional walls
of the right width, change the bars if the railing isn’t adequate. But
installing an alarm system for three ampoules and hook it up to the [police]
point…

We have regulations that do not differentiate whether
it’s a FAP, what quantities will be stored…. This is how thick the
walls must be. This is how thick the bars have to be. It is nonsense to think
that someone is going to try to get into the ambulatoria, saw through the bars,
open the safe, to get three ampoules…. But we have one law for all. No
matter whether it’s the central district hospital or a FAP.[168]

The requirements for storage premises pursue a legitimate
aim, preventing theft of controlled substances from medical channels. But they
have such a restrictive impact on the availability of these medications that
they do not balance the competing interest of availability with drug control.
As such they are inconsistent with the right to health and the principle of
balance articulated in the UN drug conventions. Ukraine needs to urgently amend
these requirements.

Prescribing Procedures

The 1961 Single Convention on Narcotics Drugs contains two
simple requirements for dispensing opioid analgesics to patients: they can be
dispensed only on a medical prescription, and a record must be kept. The
convention allows governments to impose additional requirements “if
deemed necessary or desirable,” such as requiring that all prescription
be written on official forms provided by the government or authorized
professional associations.[169]
However, as the WHO has observed, “this right must be continually
balanced against the responsibility to ensure opioid availability for medical
purposes.”[170]
The WHO Expert Committee on Cancer Pain Relief and Active Support Care has,
however, observed that special multiple-copy prescription requirements
“typically … reduce prescribing of covered drugs by 50 percent or
more.”[171]

Ukraine’s drug regulations provide for some of the
most complex and burdensome prescription procedures for opioid analgesics in
the world. While in most countries a qualified medical doctor can independently
prescribe morphine whenever he or she considers it appropriate, doctors in
Ukraine can do so only for up to three days. Any prescription beyond that
requires a decision by “Commission on Soundness of Prescription of
Narcotic Drugs,” which consists of three doctors from the institution.
The treating physician must prepare a detailed written conclusion regarding the
need for opioid analgesics, which the commission uses as the basis for making
its decision. If the commission decides opioid analgesics are in order, the
chief or a deputy chief doctor of the health facility must approve the
commission’s decision before the medications can be provided to the
patient.[172] For
any changes in dosage of the medication, the commission has to be reconvened.

Healthcare workers we interviewed consistently told us that prescribing
morphine is a time consuming process that takes anywhere from 30 minutes to 2
hours. Although most said that this does not discourage them from prescribing
the medication, a doctor at a polyclinic in Kharkiv said that while he
supported strict regulation “to a certain extent patients do suffer from
that strictness.”[173] Based
on its research, Human Rights Watch believes that the complexity of the
prescribing procedure creates a barrier to the timely initiation of treatment
with morphine for patients with pain.

While Ukraine’s prescription procedures may pursue a
legitimate aim—preventing theft and diversion of controlled
medications—they are excessively cumbersome and an impractical use of
limited medical resources. Medically, involving four doctors in prescribing
opioid analgesics is unnecessary. In most patients, managing cancer pain is not
especially complicated, no more so than many other cancer-related health
problems about which oncologists in Ukraine are allowed to make decisions independently.
Indeed, it is standard practice in most countries around the world for
individual doctors to make decisions regarding prescriptions of opioid
analgesics. A Human Rights Watch survey of barriers to palliative care in 40 countries
across the world found that only 2 countries surveyed, Russia and Ukraine,
required multiple doctors to sign off on morphine prescriptions.[174]
From a drug control perspective, the prescription procedure also seems
excessively burdensome. While Human Rights Watch is aware of allegations of
corruption in Ukraine’s healthcare sector, it should be possible to
prevent corruption with less burdensome regulations.

When doctors write prescriptions to be filled at pharmacies,
which few doctors do, they must do so on a special prescription form, popularly
known as “the red form.”[175] These
forms must be signed and stamped with the personal seal of the prescribing
doctor and of the health care establishment and must also be signed by the
chief doctor of the health care establishment or the deputy responsible for
medical matters. The prescription must be filled within 5 days of its issuance
(ordinary prescriptions in Ukraine must be filled with 30 days). A maximum of 20
ampoules of morphine can be prescribed per prescription form (see also Pharmacies
and Opioid Analgesics).

Dispensing Procedures

Ukraine’s drug regulations require that injectable
opioid analgesics from hospital stock must be administered to patients directly
by a healthcare worker even if the patient is at home.[176]
This requirement is the single most problematic provision of Ukraine’s
drug regulations.

Having nurses administer morphine directly may allow the
healthcare system to monitor the use of the medication very closely and prevent
misuse, but nothing in the UN drug conventions requires this level of control.
This system interferes with good medical care, results in significant patient
suffering, and is therefore not consistent with the requirements of the drug
conventions or the right to health.

This level of control is also unnecessary. All European
Union countries, as well as Ukraine’s other neighbors, allow patients to
take home supplies of morphine and other strong opioid analgesics.[177]
For the limited numbers of cases where a real risk of misuse exists,
prescribing doctors and administering nurses should be responsible for taking
measures to minimize that risk, monitor the patient closely, and act promptly
if there is a suspicion that medications are not being used as prescribed (see,
for example, text box on “Treating Patients in Pain with a History of
Illicit Drug Use”, p 54).[178]

Several doctors interviewed said that they felt that the
control measures were excessive. The oncologist at district 3, for example,
said:

The [level of] control
is unfounded. It is purely theoretical [that people would start selling
morphine]. It is far from practice. The patients we have really need it. The
whole family sees that. They do everything [they can] to lighten the condition
of the patient. Therefore, why would they sell them? Those who encountered this
among their own relatives will not sell it. You see your suffering
relative—you’re not going to take the morphine yourself [or sell
it].[179]

Healthcare workers at the central district hospital in
district 4, which does not comply with the requirement of direct administration
and gives patients a three-day supply of morphine to take home and administer
themselves, told us that in multiple years of giving patients or relatives injectable
morphine to take home, they have never encountered evidence of misuse. They
said that relatives faithfully return empty morphine ampoules to the clinic
when they pick up their next supply. In rare cases that relatives drop an
ampoule, healthcare workers said that they had brought back the broken pieces.[180]

The requirement is also unnecessary from a medical point of
view. Patients in Ukraine and elsewhere routinely administer other injectable
medications, such as insulin, themselves. There is no reason why, with adequate
instruction from healthcare workers, relatives cannot do the same with
morphine, particularly if it is administered subcutaneously. Indeed,
Ukraine’s regulations allow patients to administer injectable morphine
themselves if they obtain it on a prescription from a pharmacy. However, as
noted above, very few doctors in Ukraine write such prescriptions.

Record Keeping

Under the 1961 Single Convention on Narcotic Drugs,
governments must require hospitals and other institutions that handle opioid
medications to keep “such records as will show the quantities … of
each individual acquisition and disposal of drugs.”[181]
These records must be preserved for no less than two years. The convention does
not specify what kind of records must be kept, but an authoritative commentary
states that “any usual form of recording business information in an
orderly fashion would be permitted, not only in books, but also in card
files.”[182]

In Ukraine, healthcare workers document almost literally
every single movement of every single morphine ampoule. Nurses showed us an
array of journals in which they signed for a bewildering range of transactions.
The fact that morphine has been prescribed is not just recorded in the patient’s
file but also in a separate journal on opioid medications by the senior nurse,
who signs a journal at the pharmacy when she picks up the day’s supply of
morphine ampoules for her department; the nurse who administers the morphine,
who signs a journal when she picks up the ampoules, signs a second journal to
indicate that she has administered the ampoule, and then a third when she
returns the empty ampoule to the senior nurse.[183]
Finally, every ten days, the Commission on the Destruction of Empty Ampoules, comprised
of three hospital staff, including the chief or deputy chief doctor of the
institution, count and dispose of empty ampoules and sign a report confirming
how many ampoules were discarded.[184]

Healthcare workers, in particular the nurses responsible for
maintaining the various journals, told us that they take these record keeping
procedures very seriously. For many, they appeared to be a source of anxiety.
Several nurses told us they regularly recount all the ampoules, afraid that
there might be discrepancies. Others told us that any small errors in the
records could lead to significant problems in case of an inspection. Several
healthcare workers in different regions mentioned the problems they might face
if the serial number of an ampoule was accidentally wiped. In that case, they
said, it could not be certified that the empty ampoule was the same as the one
that was given out. The oncologist in district 4 said:

Before a nurse draws morphine into the syringe, she has to
disinfect it. But alcohol removes the blue serial number…. Those who
don’t know have a big problem. Once people know, they know what to do [to
avoid removing the number].[185]

Wasting
Resources in a Resource Poor Healthcare System

Lack of adequate
funding is a major problem for Ukraine’s public healthcare system.
Health worker salaries are low; buildings housing hospital and clinics often
in disrepair; and patients often have to pay for medications and other health
services that are supposed to be free. Yet, as this report demonstrates,
Ukraine spends significant resources, both financial and personnel, on
procedures with opioid analgesics, some of which are medically unnecessary
and are of questionable utility as drug control measures.

As noted, the direct administration of morphine by
healthcare workers to patients in their homes is medically not necessary and
interferes with good medical practice. But it does require significant
resources. The chief doctor of a city polyclinic told us his clinic employs
four nurses and four drivers and maintains two cars for the sole purpose to
delivering pain medications to patients. A nurse at the same facility said:

We have a special car that does nothing else but
deliver narcotics. We have a special room for the nurses, a room to rest. It
has a couch and a safe. They cannot leave the clinic any time of the day
because there may be delivery. At eight the shift changes and key and
documents are handed from one nurse to the next.

On the day we visited, the nurse said that there were
seven patients receiving opioid analgesics who needed shots at 6 a.m., 7
a.m., 9 a.m., 12 a.m., 6 p.m., 8 p.m., 10 p.m., 11 p.m. and midnight. This
occupied the nurses for the entire day. If the seven patients received an
average of two injections that day, the total work output of the two nurses
and two drivers would be fourteen injections.

In many places, ambulances are involved in delivering
morphine injections, taking time away from emergency response situations that
ambulances are meant to respond to. For example, in district 3, ambulances
service the whole district with morphine injections. On many days, it makes
half a dozen to a dozen trips, often to remote places, just to inject
morphine.

But the system also draws on the time of the doctors
who prescribe opioid medications and the nurses who are responsible for
record keeping. As mentioned, doctors estimated that preparing documents for
a single prescription of morphine takes 30 minutes to 2 hours. The chief
nurse at one central district hospital told us it takes her an average of two
hours every day to hand out morphine ampoules, receive empty ones, keep the
records and pick up a new supply from the pharmacy.

Staff at central district hospital in district 4, which
gives patients a three-day supply to take home, told Human Rights Watch that it
specifically instructs relatives to be careful not to wipe out the serial
number on the ampoules: “We warn patients to be careful.”[1]

While the Single Convention allows countries to decide what
record keeping system to put in place, Ukraine’s system seems both
wasteful of scarce healthcare resources (see text box above) and likely to
contribute to a reluctance to prescribe opioid analgesics, both because of the
time drain it represents for healthcare workers and fear that potential
mistakes in the maze of record keeping requirements could lead to investigation
and potentially administrative or even criminal sanctions. It is questionable
how much this complex accounting system actually contributes to its rationale: preventing
diversion. The Ukrainian government should explore a simpler accounting system
that does not interfere with good medical practice or waste resources.

Inspections

Under Ukrainian law, a
large array of government agencies has the right to conduct inspections of
healthcare institutions that use opioid medications. The National Drug Control
Committee, the licensing agency, conducts both routine and surprise
inspections.[186] The police and prosecutor’s office can
conduct inspections when they receive information about potential misuse of
controlled medications. The Ministry of Health and various other health agencies
also conduct inspections of healthcare institutions regarding the use of opioid
medications.

While some healthcare workers we interviewed said that their
institutions had not been inspected in several years, others complained that
the regularity of such inspections created a significant burden for staff. They
often also expressed considerable apprehension about the checks. For example,
the chief doctor in district 3 said that his hospital has faced repeated
inspections from various different government agencies related to the use of
opioid analgesics in the last year, including the narcotics committee, the
province’s health department, the pharmacological inspection, the
prosecutor’s office, the state security department, and the police
department. He complained that there did not appear to be any coordination
between these different agencies:

They come and say: “It’s your turn. We
haven’t been with you for a long time.” [I say:] “But all the
others have just been.” [They say:] “Have those been? Ok, show us
the documents.”[187]

An oncologist at a polyclinic in Kharkiv, which had also
faced multiple inspections in the last year, told Human Rights Watch:

We are afraid. If we put a comma somewhere wrong, we have
an ocean of problems. Thank God we haven't had any situation in our hospital or
the area that someone sold narcotics [illegally] or didn't prescribe correctly.
We're very strict in that sense. There may be mechanical errors, administrative
errors; in such cases, there is an administrative sanction. But we're careful.
We know the system. We teach young doctors.[188]

The inspection of healthcare institutions that work with
opioid analgesics is a normal government oversight function. However,
government agencies should ensure such inspections are conducted in a
reasonable manner so as to minimize their impact on the provision of and access
to medical care. Any potential sanctions for violations of procedures should be
proportionate and not affect patient access to pain medications.

Criminal Penalties for Mishandling Opioid
Medications

Under the 1961 Single Convention on Narcotic Drugs,
countries are required to make it a punishable offense to intentionally
distribute controlled substances in violation of the convention.[189]
In other words, a healthcare worker who deliberately provides people with
morphine for non-medical use must face criminal sanctions. However, the
convention does not require criminal sanctions for unintentional violations of
the rules of handling opioid medications. Human Rights Watch believes that
unintentional mistakes in handling such medications should not be a criminal
offense and that acts that do not constitute criminal negligence should be
subject to administrative or disciplinary oversight.

Ukraine’s criminal code—specifically the article
regarding violations of the rules for handling controlled substances—does
not differentiate between intentional and unintentional violations or consider
the consequences of the violation (although courts do). It provides for up to three
years imprisonment, other restrictions of freedom of movement for up to
four years, or a fine equivalent to fifty minimum incomes for violations of the
“rules of…storing, accounting, release, distribution,
sale…use of narcotics, psychotropic substances.”[190]
This means that nurses who make small, unintentional record keeping errors
could potentially face criminal charges, as could doctors and nurses who give
patients a take-home supply of morphine or leave loaded syringes of morphine at
patients’ homes.

A search of Ukraine’s court registry revealed several
cases of criminal prosecutions for relatively minor violations of narcotics
regulations that did not appear to have led to the diversion or misuse of
opioid analgesics. For example, in January 2007 a court in Dobrovody,
Zbarazhski district, in western Ukraine found the chief physician at an ambulatoria
guilty of failing to properly document the use of narcotic drugs and unlicensed
storage of two ampoules of tramadol. It imposed a fine of 680 hryvna
(approximately US$85) and put him on probation.[191]
In 2007 a court in Odessa province, southern Ukraine, found a surgeon guilty of
improperly documenting the medical histories and opioid prescriptions for 5
patients, imposed a fine of 510 hryvna ($64), and removed him from his post for
a year.[192] In
April 2010 the Velikobelozerskiy county court in Zaporozhskaya province in
eastern Ukraine found a midwife guilty of violating Ukraine’s drug
regulations on storage and transportation of narcotic drugs. The midwife lost
the purse in which she was carrying a seven-day supply of omnopon (twenty-one
ampoules), which exceeded the three-day limit. The court imposed a fine of 510
hryvna (US$64).[193] Human
Rights Watch believes that use of criminal law in such cases could be considered
disproportionate to the harm caused by any failure to comply with the
regulations, even if the penalties imposed are relatively light and may
contribute to an atmosphere of fear when it comes to prescribing opioid
medications. The Ukrainian government should review these rules so that
unintentional violations of the rules are no longer a criminal offense.

A December 2007 case against the deputy chief physician of
the Kamensko-Dnepr Central District Hospital in eastern Ukraine illustrates the
need for regulatory reform in Ukraine. In this case, the doctor had ordered
narcotic drugs from the district pharmacy despite the fact the hospital did not
have a narcotics license and lacked rooms that met the requirements for storage
of narcotic drugs. The prosecution alleged that the hospital and its
subsidiaries illegally acquired and stored morphine, omnopon, and fentanyl
between 2001 and 2004 but not that any of the drugs had been used for
non-medical purposes. In her defense, the doctor argued that she was initially
not aware of the requirement to obtain a narcotics license and that, when she
had become cognizant of the regulations, had taken steps to fulfill the
licensing requirements. She said that she had continued to order the
medications because “the refusal of [narcotic] drugs to patients presents
a threat to patient life and health” and would violate Ukraine’s
constitution. The court rejected the defense, sentenced her to a fine of 850
hryvna ($106), and removed her from her post for a year.[194]

The Role of Pharmaceutical Company Zdorovye Narodu

The pharmaceutical company Zdorovye Narodu is the only
company in Ukraine that supplies morphine. As such, it plays a crucial role in
ensuring that patients with pain have access to appropriate treatment. Unfortunately,
it has included a number of problematic provisions in the product information
it circulates with the injectable morphine ampoules it manufactures, including
the very low maximum daily dose recommendation discussed in Chapter III. Human
Rights Watch has unsuccessfully sought meetings with the company to discuss
these issues. A written request for clarifications was not answered.

Like other medications, morphine ampoules come with an
insert that explains their uses, contraindications, and side effects.
Unfortunately, the morphine insert contains a range of assertions that are
factually incorrect and contribute to poor pain care for patients, including:

Maximum
daily dose recommendation. The product information leaflet states:
“Maximum dosage for adults in subcutaneous injection: one time –
2ml (20mg morphine), 24 hour period – 5ml (50 mg morphine).” The
WHO guideline states that there is no maximum daily dose for morphine.

Warning
about drug dependence.The insertstates that“In
case of repeated morphine use, a psychological and physical dependency develops
quickly (in 2-14 days from the beginning of treatment).” In fact,
patients do not develop psychological dependence when they take morphine on a
doctor’s prescription. They do build up tolerance and physical dependence
over time, which the WHO calls “a normal pharmacological response.”[195]
It means that treatment with morphine should not be abruptly discontinued even
if the patient no longer experiences pain; instead, the dose of morphine should
be gradually decreased to minimize the risk of abstinence (withdrawal) syndrome
until treatment can be ended. This inaccurate information perpetuates common
misconceptions about the risk that addiction to morphine poses.

Exacerbating the impact of the erroneous information in the
insert, the Ministry of Health has included the insert’s text in its
authoritative reference book on pharmaceuticals, thus endorsing it.[196]

The Role of the INCB and UNODC

The International Narcotics Control Board, an independent
and quasi-judicial international body, has a mandate to monitor the
implementation of the 1961 Single Convention on Narcotic Drugs and other
international drug conventions. This mandate requires it to monitor efforts of
governments to implement provisions of the conventions related to the
prevention of illicit use of controlled substances, as well as efforts to
ensure their adequate availability for medical and scientific purposes.
However, it appears that in the past 10 years the INCB has monitored Ukraine’s
efforts related to illicit drugs in Ukraine much more closely than those aimed
at ensuring availability of controlled medications.

The INCB visited Ukraine in 2008 to examine its
implementation of the UN drug conventions. While representatives of the INCB
say it is standard practice to raise the issue of the availability of strong
opioid analgesics on country visits, the press statement it issued following
the visit states that it had discussed a variety of issues related to illicit
drugs but makes no mention of any discussions regarding availability of
controlled medications.[197]

A search of the INCB’s last 10 annual reports found a
total of 46 mentions of Ukraine. Of those mentions, 43 concern illicit drugs
and drug control and just 2 relate to licit drugs. (The final mention of
Ukraine is not related to either topic). In its annual report for 2008, the INCB
endorsed a new Ukrainian drug control law that strengthened control of licit
narcotic drugs but did not note Ukraine’s low consumption of morphine,
the problems caused by its overly stringent drug regulations, or make any
reference to the treaty obligation that drug control measures be balanced and
ensure adequate availability of licit drugs for medical and scientific
purposes.[198]

In a March 2011 letter to
Human Rights Watch, the INCB stated that it raised the issue of medical
availability during its 2008 mission to Ukraine. It said that it considers the
level of consumption of opioid analgesics there inadequate and that the
“subject of adequate availability will continue to be prominent in the Board’s
dialogue with the Government of Ukraine.”[199]

The UN Office on Drugs and Crime (UNODC) has a mandate to
“assist Member States in their struggle against illicit drugs, crime and
terrorism.”[200] Its
activities consist of helping enhance the capacity of member states to
counteract illicit drugs, crime, and terrorism; conducting research and
analytical work to expand the evidence base for policy and operational
decisions; and assistance with development of relevant laws and regulations.
While UNODC runs a significant number of programs aimed at HIV prevention among
drug users, including in Ukraine, it has traditionally done little to promote
drug regulations and laws that balance availability of medications with prevention
of misuse.[201] This
has recently started to change. In March 2011 UNODC presented a report to the
Commission on Narcotic Drugs on the issue of availability of opioid analgesics.
It also mentioned the issue prominently in its World Drug Report for 2009. To
date, UNODC’s work in Ukraine has not focused on ensuring that drug
regulations ensure the adequate availability of controlled medications.

V. The Human Rights Analysis

National Law

Ukraine's constitution guarantees health care free of charge
in state institutions.[202]
Ukraine's economic struggles since it gained independence in 1991 and the
resulting decline in state income have led to a significant decline in state
health care expenditures. Budget shortfalls, in turn, have led government
healthcare facilities to levy official fees for public healthcare services,
sometimes disguised as “donations” or “voluntary cost
recovery.” It is not unusual for state health care providers to also
demand “informal user fees” as a condition of receiving services.[203]

In 2002 Ukraine's Constitutional Court ruled that health
care in state and community facilities should be provided “without
preliminary, current or subsequent payments,” but stipulated that fees
could be sought for health services considered beyond the limits of health
care. Certain populations considered socially vulnerable (such as people with
disabilities, children under six, and retired persons receiving minimum
pension) are exempt from user charges or are eligible for free or reduced cost
medication or other services.[204]

The Right to Health

Health is a fundamental human right enshrined in numerous
international human rights instruments. The International Covenant on Economic,
Social and Cultural Rights specifies that everyone has a right “to the enjoyment
of the highest attainable standard of physical and mental health.”[205]
The Committee on Economic, Social and Cultural Rights, the body charged with
monitoring compliance with the ICESCR, has held that states must make available
in sufficient quantity “functioning public health and health-care
facilities, goods and services, as well as programmes,” and that these
services must be accessible.

Because states have different levels of resources,
international law does not mandate the kind of healthcare to be provided. The
right to health is considered a right of “progressive realization.”
By becoming party to the international agreements, a state agrees “to
take steps … to the maximum of its available resources” to achieve
the full realization of the right to health. In other words, high-income
countries will generally have to provide healthcare services at a higher level
than those with limited resources. But any country will be expected to take
concrete and reasonable steps toward increased services, and regression, in
many cases, will constitute a violation of the right to health.

However, the Committee on Economic, Social and Cultural
Rights has held that certain core obligations are so fundamental that states
must fulfill them. While resource constraints may justify only partial
fulfillment of some aspects of the right to health, the committee has observed
with respect to the core obligations that “a State party cannot, under
any circumstances whatsoever, justify its non-compliance with the core obligations…
which are non-derogable.” The committee has identified, among others, the
following core obligations:

To ensure the right of access to health facilities, goods, and
services on a non-discriminatory basis, especially for vulnerable or
marginalized groups.

To provide essential medicines, as compiled by the World Health
Organization.

To ensure equitable distribution of all health facilities, goods,
and services; and

To adopt and implement a national public health strategy and plan
of action, on the basis of epidemiological evidence, addressing the health
concerns of the whole population.[206]

The committee lists the obligation
to provide appropriate training for health personnel as an “obligation of
comparable priority.”

Palliative Care and the Right to Health

Given that palliative
care is an essential part of healthcare, the right to health requires that
countries take steps to the maximum of their available resources to ensure that
it is available. Indeed, the Committee on Economic,
Social and Cultural Rights has called for “attention and care for
chronically and terminally ill persons, sparing them avoidable pain and
enabling them to die with dignity.”[207]A number of different state obligations flow from this:

A negative obligation to refrain from enacting policies or
undertaking actions that arbitrarily interfere with the provision or
development of palliative care.

A positive obligation to take reasonable steps to facilitate the
development of palliative care.

A positive obligation to take reasonable steps to ensure the
integration of palliative care into existing health services, both public and
private, through the use of regulatory and other powers as well as funding
streams.

No Interference with
Palliative Care

The Committee on
Economic, Social, and Cultural Rights has stipulated that the right to health
requires states to “refrain from interfering
directly or indirectly with the enjoyment of the right to health.”[208] States may not deny or limit equal
access for all persons, enforce discriminatory health policies, arbitrarily
impede existing health services, or limit access to information about health.[209] Applied to palliative care, this obligation means that states should
ensure that their drug control regulations do not unnecessarily, and therefore
arbitrarily, impede the availability and accessibility of essential palliative
care medications such as morphine and other opioid analgesics. A balance must
be struck between preventing misuse and ensuring accessibility and availability
of medicines for licit health purposes.

Facilitating the
Development of Palliative Care

The right to health also includes an obligation to take positive measures that “enable and assist
individuals and communities to enjoy the right to health.”[210] When applied to palliative care, this means that states
should take reasonable steps in each of the three areas the WHO has
identified as essential to the development of palliative care.[211]
As noted in Chapter V, the three prongs of the WHO recommendation on palliative
care development correspond closely with several of the core obligations under
the right to health. This means that states cannot claim insufficient resources
as justification for failing to take steps in each of these three areas.[212]

Ensuring Integration of Palliative Care into Health Services

The right to health requires that states take the steps
necessary for the “creation of conditions which would assure to all
medical service and medical attention in the event of sickness.”[213]
The Committee on Economic, Social and Cultural Rights has held that people are
entitled to a “system of health protection which
provides equality of opportunity for people to enjoy the highest attainable
level of health.”[214]In other words, health services should be available for all health
conditions, including chronic or terminal illness, on an equitable basis. The committee
has called for an integrated approach to the provision of different types of
health services that includes elements of “preventive, curative and
rehabilitative health treatment.”[215]

The Prohibition of Cruel, Inhuman, and Degrading Treatment

The right to be free of cruel, inhuman, and degrading
treatment is a fundamental human right that is recognized in numerous
international and regional human rights instruments.[216]
Apart from prohibiting the use of torture and other cruel, inhuman, or
degrading treatment or punishment, the right also creates a positive obligation
for states to protect persons in their jurisdiction from such treatment.[217]

As part of this positive obligation, states have to take
steps to protect people from unnecessary pain related to a health condition. As
former UN special rapporteur on torture and other cruel, inhuman or degrading
treatment or punishment Manfred Nowak wrote in a joint letter with UN special
rapporteur on the right to health Anand Grover to the Commission on Narcotic
Drugs in December 2008:

Governments also
have an obligation to take measures to protect people under their jurisdiction
from inhuman and degrading treatment. Failure of governments to take reasonable
measures to ensure accessibility of pain treatment, which leaves millions of
people to suffer needlessly from severe and often prolonged pain, raises
questions whether they have adequately discharged this obligation.[218]

In a report to the Human Rights Council, Nowak later
specified that, in his expert opinion, “the de facto denial of access to
pain relief, if it causes severe pain and suffering, constitutes cruel, inhuman
or degrading treatment or punishment.”[219]

Not every case where a person suffers from severe pain but
has no access to appropriate treatment will constitute cruel, inhuman, or
degrading treatment or punishment. Human Rights Watch believes that this may be
the case when the following conditions are met:

The suffering is severe and meets the minimum threshold required
under the prohibition against torture and cruel, inhuman, or degrading
treatment or punishment.

The state is, or should be, aware of the level and extent of the
suffering.

Treatment is available to remove or lessen the suffering but no
appropriate treatment is offered.

The state has no reasonable justification for the lack of
availability and accessibility of evidence-based pain treatment.

In such cases, states may be liable for failing to protect a
person from cruel, inhuman, or degrading treatment. The failure of the
Ukrainian government to take steps to ensure that the healthcare system can
provide evidence-based pain treatment meets these criteria.

VI. A Way Forward: Recommendations
for Immediate Implementation

Ukraine is rapidly falling behind its neighbors with
palliative care development. On its Western borders, countries like Poland,
Hungary, and Romania have all reformed their drug regulations, introduced
training for healthcare workers, and developed increasingly well-functioning
home-based and institution-based palliative care systems. On its Eastern
borders, Georgia and Armenia are also making significant progress. Georgia,
which recently introduced oral morphine, has partially reformed drug
regulations that had many of the same problems as Ukraine’s, adopted a
national palliative care strategy, and is rolling out significant palliative
care training for healthcare workers. In Armenia, the introduction of oral
morphine is imminent as well.

Ukraine needs to follow the example of these neighbors and
move palliative care forward. It needs to urgently formulate and implement a comprehensive
strategy for developing palliative care services that includes specific steps
to overcome the various policy, regulatory, and educational barriers described
in this report. The government should draw on the experiences of its neighbors
and the expertise of WHO’s Access to Controlled Medications Programme,
the European Association of Palliative Care, and other international palliative
care experts. Ukraine should closely examine the Romanian and Georgian
experiences with regulatory reform as potential models for its own reform
efforts.

The Example of Georgia

With a common history to Ukraine as part of the Soviet
Union, Georgia has faced many of the same barriers discussed in this report.
Like Ukraine, Georgia did not have oral morphine. Multiple doctors had to
sign prescriptions for morphine, which could only be written for patients
with a biopsy-proven cancer diagnosis. Patients at home could only get a three
day (cities and regional centers) to five day (rural areas) supply of
morphine at any time. Health policies did little to support the development
of palliative care and pain treatment.

In the last few years the Georgian government has
actively sought to address these barriers. In its annual report for 2010 the
International Narcotics Control Board praised Georgia for its progress (Para
103, Report of the International Narcotics Control Board on the
Availability of Internationally Controlled Drugs: Ensuring Adequate Access
for Medical and Scientific Purposes (E/INCB/2010/1/Supp.1), see: http://incb.org/pdf/annual-report/2010/en/supp/AR10_Supp_E.pdf
(accessed March 14, 2011).)

In 2008 the Georgian government amended healthcare
laws to incorporate palliative care, providing patients with a right to
palliative care on par with preventive, curative, and rehabilitative care. Georgia’s
parliament adopted a national palliative care action plan. In 2009 the
government introduced oral morphine in the public healthcare system, which is
now available for outpatients and increasingly also for inpatients.

In 2008 Georgia amended its drug regulations to
eliminate the requirement that multiple doctors sign prescriptions for strong
opioid analgesics. In 2010 drug regulations were further amended to allow all
trained physicians, as opposed to just oncologists, to prescribe strong
opioid analgesics and remove the requirement of a biopsy-confirmed diagnosis
for such prescriptions. Patients and their relatives can receive a seven-day
take-home supply of morphine and administer the medication themselves.

Georgia has also made instruction in modern pain
management available in undergraduate medical programs at state medical
universities. At Tbilisi State University, it is a compulsory part of the
curriculum; at three other universities it is optional. Instruction in pain
management is available in post-graduate medical education in the country.
For the last five years palliative care instruction has been available as
part of continuing medical education.

Despite this progress, significant barriers remain. Inexpensive
instant-release morphine is still unavailable in Georgia; many healthcare
workers have yet to have training in palliative care; and patients have to
fill prescriptions for morphine at special pharmacies located in police
stations which have limited opening hours.

Email correspondence with Dr. Pati Dzotsenidze of
the Tbilisi State University, Faculty of Medicine and the Institute for
Cancer Prevention and Palliative Medicine, Department of Pain Policy,
February 28, 2011.

Below, Human Rights
Watch makes two sets of recommendations. The first addresses issues that must
be remedied immediately because of their profound negative impact on good
patient care. The second group contains recommendations that require a certain
amount of time and cannot be implemented overnight. However, we urge the
government to move on these recommendations expediently as they are all
critical to ensuring good palliative care availability.

To the Ukrainian Government

Immediately:

Ensure
the availability of oral morphine. Actively engage Zdorovye
Narodu and other pharmaceutical companies to introduce oral morphine. The
public healthcare system should carry oral morphine at all levels of care.

Abolish the requirement that injectable morphine and other injectable strong pain
medications be administered by healthcare workers to patients at home.
In consultation with medical doctors, the WHO, and other relevant experts,
provide new standards for take home medicine to ensure a continuous supply of
pain medications. For example, in areas with a functioning delivery
service, healthcare facilities could be allowed to provide patients with at
least a seven-day supply to ensure a continuous supply of pain medications. In
rural areas, where access to clinics with a narcotics license is problematic,
healthcare facilities could be allowed to provide patients with at least a
fourteen-day supply.

Change
licensing requirements for rural clinics. Requirements for
narcotics licenses must be such that all rural clinics can obtain such license,
including FAPs. In particular, the government should review whether imposing
the requirement of a separate storage room on rural clinics is necessary and a
proportionate measure to protect against misappropriation and whether a
suitable safe would achieve similar results. It should ensure that health
clinics can obtain a license with a simple sound and light alarm system rather
than a system with a police hookup. If a policy decision is made to leave
costly requirements, the state should provide adequate budget allocation for
health clinics to meet those costs.

Disseminate
the WHO pain treatment guideline to all healthcare facilities. The
Ministry of Health should urge all doctors to follow the guideline’s
recommendations for assessing and treating pain based on accurate
pharmacological principles.

Provide
in-service training on the pain treatment guidelines for doctors
throughout the public health system.

The government should also, in conjunction with all relevant
stakeholders, including civil society groups, undertake the following steps:

In the Area of Policy

Develop
a home-based palliative care system. Review staffing
structures for healthcare facilities so that hospices and other facilities
can provide home-based palliative care; provide funds to hospices to
develop such services; reform the current system for delivering strong
pain medications through nurse visits to patients’ homes into a
palliative care delivery system.

Develop
palliative care and pain treatment guidelines. The Ministry of Health,
medical colleges, palliative care providers, and relevant civil society
groups should develop a palliative care and pain treatment guideline based
on international best pharmacological and practice evidence. This
treatment guideline should be widely disseminated among all relevant
healthcare workers and form the basis for training healthcare workers on
palliative care and pain management.

Ensure
palliative care integration into disease control strategies. National
cancer and HIV/AIDS control programs and other relevant disease control
strategies should have a robust palliative care component, list detailed
steps aimed at integrating palliative care into these strategies, and
provide for specific and adequate allocations of resources for palliative
care development.

In the Area of Education

Introduce
palliative care instruction into medical and nursing curricula.
Establish a clear standard for education in palliative care and pain
treatment to ensure that all healthcare providers have at least basic training
in the discipline. Healthcare providers who see large numbers of patients
in need of palliative care should receive in-depth training and exposure
to clinical practice.

Exams
for medical and nursing licenses should include questions about
palliative care and pain management.

Mandate
rotations in palliative care. The Ministry of Health should
mandate rotations in palliative care units for students of certain
postgraduate programs, including oncology, geriatrics and infectious
disease, to ensure clinical exposure to palliative care.

Develop
training modules. The Ministry of Health should translate
key palliative care resources into Ukrainian and develop training modules
for doctors, nurses, social workers, counselors, and volunteers, in
cooperation with hospices, civil society groups, and international palliative
medicine experts.

Provide
continued medical education. Palliative care and pain
management should be included in mandatory continued education programs
for all general practitioners, oncologists, infectious disease doctors,
anesthesiologists, and geriatrists. Questions about palliative care
and pain management should be included in exams for physicians and nurses
following these courses.

In the Area of Drug Availability

Using the WHO’s assessment tool, “Ensuring
Balance in Controlled Substance Policies,” Ukraine should initiate a
thorough review of its drug regulations and amend them so that they ensure
adequate availability of strong opioid analgesics, while also being capable of
minimizing the risks of misuse that exist in Ukraine. Particular attention
should be paid to the following issues:

Licensing
requirements. These requirements should be as least burdensome as
possible, while providing protection against diversion and theft. In rural
clinics, the government should consider whether a solid safe would generally be
adequate protection for the small amounts of opioid medications they are likely
to stock.

Take-home
medications. It is standard practice in many countries around the world
to provide patients with a two-week to one-month take-home supply of morphine.

Accounting
procedures should be simplified to minimize waste of limited
resources.

Number
of signatures per prescription should be reduced. Doctors in most countries
can make individual decisions to prescribe opioid medications.

To Zdorovye Narodu

Amend
the product information for injectable morphine to bring it in line with
available evidence. The maximum daily dose recommendation and inaccurate
information on the risk of psychological dependence should be removed as out of
line with international standards.

Start
manufacturing oral morphine. Oral morphine can be introduced through a
so-called bio-waver, as no clinical trial or other costly procedures are
required for its introduction.[220]
Ukraine’s essential medicines list and list of medications that can be
bought from state funds include morphine—without specifying the
formulation—so oral morphine could be distributed through the public
healthcare system.[221]

To the International Community

To the International Narcotics Control Board

Consistently report in the annual report on the availability of
controlled substances for medical and scientific purposes in countries,
including on specific barriers that impede such availability.

Raise concern about the problems with availability of opioid
analgesics raised in this report in follow-up efforts to its 2008 mission to
Ukraine. In particular, the INCB should request information from the government
about its efforts to ensure adequate availability of controlled substances for
medical and scientific purposes and about remaining barriers. Information on
this correspondence should be included in subsequent annual reports.

Offer technical support to Ukraine in reviewing and amending
current drug regulations.

To the World Health Organization and UN Office on
Drugs and Crime

Raise concerns with the Ukrainian government about the problems
with availability and accessibility of controlled medications identified in
this report.

Urge the government to use the WHO tool for assessing drug
policies to review its regulations and offer technical assistance.

The WHO Access to Controlled Medications Programme should offer
technical assistance to the Ukrainian government on drug regulatory reform and
educational barriers.

Urge the government to implement resolution 53/4 of the
Commission on Narcotic Drugs.

To the European Union

Raise concerns about the limited availability of palliative care
and pain treatment in Ukraine as part of its structured human rights dialogue
and other relevant bilateral and multilateral dialogues with the Ukrainian
government, including in the context of the Association Agreement preparatory
process currently underway. Ensuring adequate availability of palliative care
and pain treatment should feature among the benchmarks articulated for Ukraine.

Offer financial and technical assistance to the government of
Ukraine to review and amend drug regulations, develop palliative care policies,
and introduce palliative care instruction for healthcare workers. Consider
involving partners in the EU-funded Access to Opioid Medication in Europe
(ATOME) in this assistance.[222]

Offer funding and technical assistance for the development of
Ukrainian palliative care and pain treatment guidelines.

To the Council of Europe

The Council of Europe has recommended that member states
ensure the availability of palliative care.[223]
However, its recommendations have, to date, not adequately addressed the
significant problems that exist in Council of Europe states with regard to
availability of opioid medications. To address this shortcoming:

The Commissioner for Human Rights should take up the issue of
access to pain treatment medications and palliative care more generally, as
part of his work, including specifically in Ukraine.

The Parliamentary Assembly of the Council of Europe should
appoint a rapporteur to look into the question of availability of pain treatment
medications and relevant laws in the Council of Europe region, including in Ukraine.

The Committee of Ministers should encourage all Council of Europe
countries to review their drug regulations using the tool WHO has developed for
this purpose.[224]

To International Donors, in particular the Global
Fund against AIDS, Tuberculosis and Malaria, the US and EU Governments

Ensure that palliative care and pain management are an integral
part of any programs that are funded to provide care and treatment services to
people living with HIV and AIDS.

Require that supported healthcare institutions obtain a license
for morphine and other opioid analgesics and maintain an adequate stock of
these medications.

Financially support training of healthcare workers at AIDS
centers and community care centers on palliative care and pain management.

Acknowledgments

Research for this report
was conducted by Diederik Lohman, senior researcher with the Health and Human
Rights Division of Human Rights Watch, jointly with Andrei Rakhansky of the
Institute of Legal Research and Strategies in Kharkiv, Anna Kotenko of the
Rivne branch and Alena Druzhinina of the Kiev branch of the All-Ukrainian
Network of People Living with HIV. Diederik Lohman wrote the report. It was
reviewed by Joseph Amon, director of the Health and Human Rights Division of
Human Rights Watch; Rachel Denber, deputy director of the Europe and Central
Asia Division of Human Rights Watch; Veronika Szente Goldston, advocacy
director of the Europe and Central Asia Division of Human Rights Watch; Aisling
Reidy, senior legal advisor at Human Rights Watch; and Danielle Haas, senior
editor in the Program Office of Human Rights Watch. The report was also
reviewed by Dr. Kathleen Foley of Memorial Sloan Kettering Cancer Center, Dr.
Frank Ferris, director of international programs at the Institute for
Palliative Medicine at San Diego Hospice, Kseniya Shapoval and Victoria
Tymoshevska of the International Renaissance Foundation, Ludmila Andriishin of
Ivano-Frankivsk hospice, and Andrei Rakhansky of the Institute of Legal
Research and Strategies.

We are deeply grateful to the
palliative care patients and their relatives in Ukraine who, despite battling
serious illness, agreed to be interviewed for this report. We will use their
testimonies and this report to fight for better palliative care in Ukraine so
others who develop life-threatening illness—and pain and other symptoms
associated with it—will not have to endure the suffering they faced. Similar
gratitude goes to the many doctors, nurses, and government officials who spoke to us frankly about
pain treatment practices in Ukraine. Without them, this manuscript would not
have been possible.

We further thank Dr.
Thomas Dzierzanowski, a palliative care physician from Poland, Dr. Pati
Dzotsenidze of the Tbilisi State University, Faculty of Medicine and Institute
for Cancer Prevention and Palliative Medicine, Department of Pain Policy, Dr.
Eric Krakauer, director, International Programs, Harvard Medical School Center
for Palliative Care, Dr. Stephen Passik, Memorial Sloan Kettering Cancer
Center, Pavlo Skala of the International HIV/AIDS Alliance in Ukraine, and Viktor Serdiuk and Olga Skorina of the All-Ukrainian Council for Patients' Rights and Safety for
their help with various sections of this report.

[5]
A camera crew of the Open Society Institute filmed Vlad in May 2010 for a
documentary about his case.

[6]
While palliative care is often associated with terminal illness, it can benefit
patients with a much broader group of illnesses or health conditions.
Palliative care advocates use the term “life-limiting” illness or
health condition to delineate the group of patients who would benefit from the
services provided by palliative care, including symptom control, pain
treatment, psychosocial and spiritual support and others. A life-limiting
illness or health condition is a chronic condition that limits or has the
potential to limit the patient’s ability to lead a normal life and
includes, among others, cancer, HIV/AIDS, dementia, heart, renal, and liver
disease, and permanent serious injury.

[7]
The WHO estimates that on average about 60 percent of people who die would
benefit from palliative care before death. See Stjernsward and Clark,
“Palliative Medicine: A Global Perspective” in Doyle et al, eds., Oxford Textbook of
Palliative Medicine, 3rd edition. In Ukraine, with a population of
45.4 million and a death rate of 15.7 per 1,000 this translates to an estimated
428 thousand individuals each year who could benefit from palliative care. (US
Central Intelligence Agency, The World Fact Book, 2010,
https://www.cia.gov/library/publications/the-world-factbook/geos/up.html
(accessed January 3, 2011)

[12]A 2010 report by the Ministry of Health for UNAIDS found
neither “home-based care” nor “palliative care and treatment
of common HIV-related infections” available to the majority of people in
need. Ministry of Health of Ukraine, “Ukraine: National Report on
Monitoring Progress towards the UNGASS Declaration of Commitment on
HIV/AIDS,” 2010, p. 103, http://data.unaids.org/pub/Report/2010/ukraine_2010_country_progress_report_en.pdf (accessed February 28, 2011).

[16]
In Ukraine, three strong opioid analgesics are used to treat moderate to severe
pain: morphine, omnopon and promedol. Omnopon is a cocktail of morphine,
codeine and several other substances. Promedol is a synthetic opioid. Both
omnopon and prodemol are weaker than morphine.

[17]
Human Rights Watch and Institute of Legal Research and Strategies interview
with nurse in district 1, April 16, 2010.

[19]
Formulary availability and regulatory barriers to accessibility of opioids for
cancer pain in Europe: a report from the ESMO/EAPC Opioid Policy Initiative, N.
I. Cherny, J. Baselga, F. de Conno and L. Radbruch, Annals of Oncology Volume
21, Issue 3 Pp. 615-626. This survey covered all European countries with
the exception of Armenia, Azerbaijan, Malta and San Marino. It did not cover
most Central Asian countries. Like Ukraine, Armenia and Azerbaijan do not have
any oral morphine;

[27]
Order 11 of 2010 of the Ministry of Health on the procedure of handling narcotic
drugs, psychotropic substances and precursors at healthcare facilities of
Ukraine.

[28]Human Rights Watch meeting with Volodymyr
Tymoshenko, head of the National Drug Control Committee, Kiev, October 22,
2010.

[29]Joint letter by the UN special rapporteur
on the prevention of torture and cruel, inhuman or degrading treatment or
punishment, Manfred Nowak, and the UN special rapporteur on the right of
everyone to the enjoyment of the highest attainable standard of physical and
mental health, Anand Grover, to the Commission on Narcotic Drugs, December
2008. A copy of the letter is available at http://www.ihra.net/Assets/1384/1/SpecialRapporteursLettertoCND012009.pdf
(accessed January 16, 2009).

[31]
Pain is also a symptom in various other diseases and chronic conditions and
acute pain is often a side-effect of medical procedures. This paper, however,
focuses on pain and other symptoms due to life-limiting illnesses.

[41]
United Nations Economic and Social Council (ECOSOC), "Single Convention on
Narcotic Drugs of 1961, as amended by the 1972 Protocol amending the Single
Convention on Narcotic Drugs, 1961," preamble, http://www.incb.org/incb/convention_1961.html
(accessed January 15, 2009).

[49]
An ambulatoria is an outpatient clinic. A feldshrsko-akusherski punkt is
a health point that provides basic procedures, including prenatal care and
first aid. These health centers are run by feldshers, physician
assistants trained in vocational medical schools and provide routine checkups,
immunizations, and emergency first-aid, and midwives. There are no physicians
at these clinics.

[58]Feldshers are physician assistants trained
at nursing schools and provide routine checkups, immunizations, and emergency
first-aid. While some feldshers are supervised by doctors in large hospitals,
many work in rural areas where they run small outpatient posts.

[59]Human Rights Watch and Institute of Legal
Research and Strategies interview with the district oncologist in district 2,
April 16, 2010.

[60]
All-Ukrainian Network of People Living with HIV, Rivne branch, interview with
the chief doctor of the central district hospital in district 5, May 12, 2010.

[61]
Human Rights Watch and Institute of Legal Research and Strategies interview
with nurse in district 1, April 16, 2010.

[62]
Human Rights Watch and Institute of Legal Research and Strategies interview
with Yakiv Kovalenko (not his real name), April 16, 2010.

[63]
Human Rights Watch and Institute of Legal Research and Strategies interview
with nurse in district 1, April 16, 2010.

[73]Human Rights Watch and International
Renaissance Foundation meeting with Volodymyr Tymoshenko, head of the National
Drug Control Committee, Kiev, October 22, 2010. In follow-up conversations,
Tymoshenko has told the International Renaissance Foundation that Odessa
province also has only four pharmacies with narcotics licenses and that Crimea
has just seven.

[74]
Ministry of Health Order 11 of January 21, 2010, para. 3.8; and Ministry of
Health Order 360 of July 19, 2005.

[84]
UN Committee on Economic, Social and Cultural Rights, General Comment No.
14:The right to the highest attainable standard of health, November 8, 2000,
para. 12. The Committee on Economic, Social and Cultural Rights is the UN body
responsible for monitoring compliance with the International Covenant on
Economic, Social and Cultural Rights.

[88]
Formulary availability and regulatory barriers to accessibility of opioids for
cancer pain in Europe: a report from the ESMO/EAPC Opioid Policy Initiative, N.
I. Cherny, J. Baselga, F. de Conno and L. Radbruch, Annals of Oncology Volume
21, Issue 3 Pp. 615-626. This survey covered all European countries with
the exception of Armenia, Azerbaijan, Malta and San Marino. It did not cover
most Central Asian countries. Like Ukraine, Armenia and Azerbaijan do not have
any oral morphine.

[92]
Human Rights Watch and Rivne Branch of All-Ukrainian Network of People Living
with HIV interview with Svitlana Bulanova (not her real name), April 21, 2010.

[93]
Human Rights Watch and Rivne Branch of All-Ukrainian Network of People Living
with HIV interview with a nurse of of the central district hospital.

[94]
Human Rights Watch and Rivne Branch of All-Ukrainian Network of People Living
with HIV interview with the chief nurse at a polyclinic in Rivne, April 19,
2010; Human Rights Watch interview with doctor at hospice, April 23. 2010.

[95]
All-Ukrainian Network of People Living with HIV, Rivne branch, interview with
the chief doctor of the central district hospital in district 5, May 12, 2010.

[122]
Human Rights Watch and Rivne Branch of All-Ukrainian Network of People Living
with HIV interview with Roman Baranovskiy (not his real name), April 21, 2010.

[123]
Human Rights Watch and Rivne Branch of All-Ukrainian Network of People Living
with HIV interview with an oncologist at a hospital in Rivne, April 21, 2010.
While patients who have a history of treatment with promedol or omnopon
may require increased doses of morphine because they have built up some
tolerance to opioids, most doctors prescribe these medications in full ampoules
as well, without determining the right dose for the individual patient.

[126]
Human Rights Watch and Institute of Legal Research and Strategies interview
with a doctor at the hospice in Kharkiv, April 12, 2010. Email correspondence
with Liudmila Andrishina, chief doctor of the Ivano-Frankiivsk hospice,
February 25, 2011.

[127]
The findings of this survey will be published in a forthcoming Human Rights
Watch report on the global state of palliative care. The maximum dose in Turkey
is 200 mg of oral morphine.

[128]
Human Rights Watch and Rivne Branch of All-Ukrainian Network of People Living with
HIV interview with a doctor at a polyclinic in Rivne, April 19, 2010.

[129]
All-Ukrainian Network of People Living with HIV, Rivne branch, interview with
the chief doctor of the central district hospital in district 5, May 12, 2010.

[130]
Human Rights Watch and Rivne Branch of All-Ukrainian Network of People Living
with HIV interview with a doctor at a polyclinic in Rivne, April 19, 2010.

[131]
Human Rights Watch and Institute of Legal Research and Strategies interview
with the district oncologist in district 3, April 14, 2010.

[140]
UN Committee on Economic, Social and Cultural Rights, “Substantive Issues
Arising in the Implementation of the International Covenant on Economic, Social
and Cultural Rights,” General Comment No. 14, The Right to the Highest
Attainable Standard of Health, E/C.12/2000/4 (2000),
http://www.unhchr.ch/tbs/doc.nsf/(Symbol)/40d009901358b0e2c1256915005090be?Opendocument
(accessed May 11, 2006), para. 12b.

[141]
Human Rights Watch and All-Ukrainian Council for the Rights and Safety of
Patients with Natalya Malinovska, Kiev, October 20, 2010.

[145]UN Committee on Economic, Social and Cultural
Rights, “Substantive Issues Arising in the Implementation of the
International Covenant on Economic, Social and Cultural Rights,” General
Comment No. 14, The Right to the Highest Attainable Standard of Health,
E/C.12/2000/4 (2000),
http://www.unhchr.ch/tbs/doc.nsf/(Symbol)/40d009901358b0e2c1256915005090be?Opendocument
(accessed May 11, 2006), para. 43.

[149]
Email correspondence with Ludmila Andrishina, January 5, 2011; correspondence
with Olesya Bratyun, executive director of the Al-Ukrainian League for the
Development of Palliative and Hospice Care, April 8, 2011.

[150]Letter from Yuri Gubski, the head of the
department of palliative and hospice care of the National Medical Academy for
Continuing Education, to chief doctors of healthcare institutions, December 24,
2010. The letter is on file with Human Rights Watch.

[154]
Preamble of the 1961 Single Convention on Narcotic Drugs, https://www.incb.org/convention_1961.html;
and INCB, “Availability of Opiates for Medical Needs: Report of the
International Narcotics Control Board for 1995,”
p. 14, http://www.incb.org/pdf/e/ar/1995/suppl1en.pdf (accessed
September 25, 2009).

[161]
Human Rights Watch meeting with Volodymyr Tymoshenko, head of the National Drug
Control Committee, Kiev, October 22, 2010. Human Rights Watch meeting with
Elena Koval, section on licit narcotics circulation of the Ministry of
Interior, October 22, 2010.

[162]Human Rights Watch meeting with Volodymyr
Tymoshenko, head of the National Drug Control Committee, Kiev, October 22,
2010.

[163]
Licenses are issued within ten days of submitting the application with all
relevant documentation for a five-year period. Article 11 of the Law on
Narcotic Substances, Psychotropic Substances and Precursors of February 15,
1999 (as amended on December 22, 2006), Directive of the Cabinet of Ministers
of Ukraine “On Approval of the List of Documents that Must Be Added to
the Application for License for Certain Types of Economic Activities No. 756 of
July 4, 2001.

[164]
Ministry of Health Order 356, the predecessor to Order 11, stated specifically
that FAPs could receive opioid medications. That provision has been dropped
from Order 11 so FAPs are no longer identified as health institutions that can
obtain a narcotics license.

[165]
Article 11 of the Law on Narcotic Substances, Psychotropic Substances and
Precursors of February 15, 1999 (as amended on December 22, 2006), Directive of
the Cabinet of Ministers of Ukraine “On Approval of the List of Documents
that Must Be Added to the Application for License for Certain Types of Economic
Activities No. 756 of July 4, 2001.

[166]
Ministry of Internal Affairs Order 216 of May 15, 2009 on the
“Requirements to Objects and Premises Designated for Conducting Activity
related to Circulation of Narcotic Drugs, Psychotropic Substances, Precursors,
and Storing of such Drugs and Substances Seized from Illegal
Circulation”; Ministry of Health Order 11 of January 21, 2010.

[167]
Human Rights Watch and Institute of Legal Research and Strategies interview
with the chief doctor of the central district hospital in district 3, April 14,
2010.

[178]
In the United States, the Federation of State Medical Boards has developed a
guideline on pain treatment that outlines the responsibilities of medical
doctors related both to the provision of pain management and the prevention of
misuse of opioid medications. These include, among others, careful evaluation
of patients, periodic review of treatment plan, keeping of accurate and
complete medical records and compliance with controlled substances regulations,
http://www.medsch.wisc.edu/painpolicy/domestic/model.htm
(accessed February 24, 2011).

[179]
Human Rights Watch and Institute of Legal Research and Strategies interview
with the district oncologist in district 3, April 14, 2010.

[180]
Human Rights Watch and Rivne Branch of All-Ukrainian Network of People Living
with HIV interview with the head nurse of the central district hospital in
district 4, April 21, 2010.

[183]
Article 34 of the Law on Narcotic Drugs, Psychotropic Substances and
Precursors; Section 16 and Addendum 5 to Directive 589 of June 3, 2009 of the
Cabinet of Ministers on the “Order of Conducting Activity Related to
Turnover of Narcotic Drugs, Psychotropic Substances and Precursors”; and
para. 3.13 and 3.14 of the Ministry of Health Order 11 of January 21, 2010.

[184]
Ministry of Health Order 11 of January 21, 2010, para. 1.10 and 1.11.

[185]
Human Rights Watch and Rivne Branch of All-Ukrainian Network of People Living with
HIV interview with the deputy chief doctor of the central district hospital in
district 4, April 21, 2010.

[186]
Order on the State Committee of Ukraine on Drugs Control adopted by Directive
of the Cabinet of Ministry No. 676 of July 28, 2010; Section 45 of the
Order on Conducting Activity Related to Circulation of
Narcotics, Psychotropic Substances and Precursors, and Controlling of
their Circulation, adopted by Directive of the Cabinet of Ministry No. 589 of
July 03, 2009.

[187]
Human Rights Watch and Institute of Legal Research and Strategies interview
with the chief doctor of the central district hospital in district 3, April 14,
2010.

[188]
Human Rights Watch and Institute of Legal Research and Strategies interview
with a chief doctor at a polyclinic in Kharkiv, April 13, 2010.

[190]
Article 320(1) of Ukraine’s criminal code. The provision also provides
for a three-year ban on certain types of employment and activities. In cases where
the violation of the rules on handling controlled substances led to large
quantities of missing narcotic drugs or where a person used their official
position to steal, embezzle, or misappropriate narcotic drugs, the offense is
punishable by the fine of up to the equivalence of 70 minimum incomes or three
to five years of imprisonment, with prohibition to occupy certain employment
positions or perform certain activity for up to 3 years (Article 320(2)).

[201] In fact,
UNODC’s own model drug laws are not based on the principle of balance.
See: the Model Law on the Classification of Narcotic Drugs, Psychotropic
Substances and Precursors and on the Regulation of the
Licit Cultivation, Production, Manufacture and Trading of Drugs; the Model
Regulation Establishing an Interministerial Commission
for the Coordination of Drug Control; and the Model Drug Abuse Bill,
http://www.unodc.org/unodc/en/legaltools/Model.html
(accessed January 24, 2009); A detailed analysis of provisions regarding
controlled medications in the model laws
and regulations can be found in a January 2009 report by the Pain & Policy
Studies Group, entitled “Do International Model Drug Control Laws Provide for Drug
Availability?” UNODC has recognized this problem and is planning on
making the necessary changes to its model laws.

[202]
Constitution of Ukraine, art. 49 ("The State creates conditions for
effective medical service accessible to all citizens. State and communal health
protection institutions provide medical care free of charge; the existing
network of such institutions shall not be reduced.").

[206]
UN Committee on Economic, Social and Cultural Rights, General Comment No. 14.

[207]
Ibid., para 25. While the committee included this reference in a paragraph on
the right to health for older persons, the wording clearly indicates that it
applies to all chronically and terminally ill persons.

[217]UN Human
Rights Committee, General Comment 20, para. 8,
http://www.unhchr.ch/tbs/doc.nsf/(Symbol)/6924291970754969c12563ed004c8ae5?Opendocument
(accessed August 29, 2009). See also the judgment of the European Court of
Human Rights in Z v United Kingdom (2001) 34 EHHR 97.

[218]
Joint letter by the UN special rapporteur on the prevention of torture and
cruel, inhuman or degrading treatment or punishment, Manfred Nowak, and the UN
special rapporteur on the right of everyone to the enjoyment of the highest
attainable standard of physical and mental health, Anand Grover, to the
Commission on Narcotic Drugs, December 2008. A copy of the letter is available
at http://www.ihra.net/Assets/1384/1/SpecialRapporteursLettertoCND012009.pdf
(accessed January 16, 2009).

[219]Human
Rights Council, Report of the Special Rapporteur on torture and other cruel,
inhuman or degrading treatment or punishment, Manfred Nowak, A/HRC/10/44,
January 14, 2009,
http://daccessdds.un.org/doc/UNDOC/GEN/G09/103/12/PDF/G0910312.pdf?OpenElement
(accessed August 4, 2009), para. 72.

[220]
Human Rights Watch interview with Olga Baulia, State Expert Center of the
Ministry of Health, October 21, 2010.